www.unitedbiotechindia.com United Biotech Pvt Ltd Delhi : DRA Drug Regulatory Affairs Executive

[Admin]

unitedbiotechindia.com

United Biotech an emerging force in Indian Health Care Industry, which has technical collaborations with number of MNC's and Provide an environment which is full of challenges to its employees.We always recognized that its greatest strength is its, People. We Value our PEOPLE as RESOURCE and keep it as, an ASSET.

We work as a team mutually, differently, ethically in a most efficient manner to inculcate innovation and creativity. Our motive is to sharpen employee skills set by offering them Careers not only Jobs. We provide work satisfaction and space where, employees can develop themselves through our various training programs.

Designation Drug Regulatory Affairs - Executive / Sr. Executive

Job Description
1. Preparation of Registration & Export/ Import dossiers of pharmaceutical formulation for CIS, US & European Countries
2. Liasioning with Government Authorities for regulatory approval.
3. Awareness about CTD Formats and CTD Modules details.
4. Independently handling of all dossiers as per country requirements.
5. Co- ordination with R & D, QA / QC for preparation of dossiers.
6. To conduct experimental analysis for the assigned project/s, required to study and develop new formulations/products for Regulated market and assist in scaling-up and technology transfer.

Desired Profile
· Must be from Science / Pharmacy background with Min 1 Years of Experience in same line
· Excellent command over written and verbal English communication.
· Must be Proficient in Computer skills and business communication
· Should be self motivated and result oriented
· Should be initiator , keen learner , proactive and good analytical skills
· Should have pleasing and presentable personality.
· Candidate from South Delhi, Central Delhi and Faridabad will be preferred more.

Experience 1 - 4 Years
Location Delhi
Keywords DRA , Drug Regulatory Affairs , Quality Assurance QA , CTD Dossiers, Registration

Contact
United Biotech Pvt Ltd
FC/B-1 ( Ext )
Mohan Co-operative Industrial Estate
Mathura Road
New Delhi,Delhi,INDIA 110044
Website http://www.unitedbiotechindia.com

[Guest]

JIGYASA BEDI
Emailjigggi AT gmail.com

OBJECTIVE :
To work in a challenging and motivating environment where I can learn, innovate and create exceptional value in the competitive world,not merely by learning the existing
But creating something new to be learnt.

PROFESSIONAL QUALIFICATION :
Pursuing B.Tech in Biotechnology(8th semester) (2005 2009 batch) at AMITY INSTITUTE OF BIOTECHNOLOGY (AIB), NOIDA
CGPA OF SIX SEMESTERS7.02/10

EDUCATIONAL QUALIFICATION :
EXAM YEAR INSTITUTION SUBJECTS %MARKS
CBSE 2004 Sri Guru Harkrishan public School Physics, Chemistry, Biology, P.E. & English. 78.4
CBSE 2002 Sri Guru Harkrishan public School English, Hindi, Maths, Science, Computers
Social Science 77.3

INDUSTRIAL TRAINING :
Ranbaxy ,Paunta Sahib ,Uttrakhand
Duration : 15 june’07 to 1 july’07
Descrpition : Worked in microbiology department and learnt the large scale fermentation and production of drugs.
Punjab Agricultural University, Ludhiana ,Punjab
Duration : 2nd july’07 to 1st aug’07
Description : Worked in plant tissue culture lab and learnt how different plant are grown by tissue culturing and also learnt the techniques to modify genetic constitution of the plant in order to improve the variety of plant.

SEMINARS ATTENDED :
Participated in an International Level Seminar on Biodiesels in 2006 held at Amity Jaipur Campus. (Member of the organizing committee).
Participated in national level seminar on IT (SETA) in 2006(member of organizing committee)
Attended seminar on “Road map to success” by Mr.Anup Jalota

SKILLS :
Programming languages. C , C ++, HTML
Learning Database management systems
Good presentation skills
Good creative skills of art & craft and writing.

AWARD AND ACHIEVEMENTS :
Won first prize in inter-zonal competition of Web-page Designing organized by Lions Club in 2002.
Won second prize and one year scholarship in district level painting competition organized by Castrol and Compucom in 2001.
Won 3 consecutive awards for social service by Help Age India in 2001,-02,-03.
Frequently participated in debate competitions and extempore.

PERSONAL INFORMATION :
Date of Birth : 06th July 1986
Father’s Name : Mr. Mahesh Pal Bedi
Languages known : Hindi, English, Punjabi(spoken) , Learning French.
Interests : Learning new techniques, Interacting with people, art & craft

[Guest]

PHANEENDRA KURAPATI
Email : indrapharma AT gmail.com

Career Objective :
Eager to work diligently in challenging circumstances to enlighten proficiency and to increase the harvest of the company

Areas of Interest :
Drug Regulatory affairs, Intellectual property rights, and Formulation development.
Academic Profile

Academic profile :
1) Pursiung M.S.,Pharmaceutics from National Institute of Pharmaceutical Education and Research (NIPER), Mohali (Will be completed till June 30th 2009) CGPA got 7.74 out of 10 (up to third semister)
2) Got B. Pharmacy from Andhra University, India in 2007 with 74.54%

Research Project :
Project Title :
Development of controlled release formulation using carboplatin loaded microspheres in paclitaxel loaded hydrogel
Principal Investigator :
Dr. Neeraj kumar
Assistant Professor, Department of Pharmaceutics, NIPER
Major objective :
Carboplatin and paclitaxel combination is a FDA approved combination for treatment of several cancers. Localized delivery of these two drugs using biodegradable thermoreversible hydrogel (PLGAPEGPLGA) having microspheres (PLA) will produce controlled delivery of these two drugs for a sustained period of time. In an attempt to achieve this objective, carboplatin loaded microspheres were dispersed in paclitaxel loaded hydrogel.

Skills :
1)Computer proficiency :
Proficient in MS Power Point, Excel, Word; Reference Management Software (End Note Plus), Sigma Stat, Sigma Plot; Chemoffice, Scientific Information Retrieval using search engines on internet.
2) English fluency

Achievements :
All India rank (AIR) 34th in GATE
AIR 273th in GATE
Pratibha scholarship (During B.Pharmacy, prize money Rs.17, 500/ every year) by State Government of Andhra Pradesh, India. Awarded for 1st rank in E.CET2004 pharmacy (Engineering Common Entrance Test).
Completed distance learning course in “Fundamentals of intellectual property rights” form WIPO (World Intellectual Property Organization)

In house Seminars Presented :
Doctrine of Equivalents
Marketing Exclusities USFDA perspective

Personal Information :
Date of Birth : 05051984
Father’s Name : Venkata Subbarao Kurapati
Nationality : Indian
Languages Known : Telugu, Hindi and English

[mahendrakuril]

Mahendra Kuril
e-mail : mahendrakuril AT gmail.com

OBJECTIVE :
To work in a challenging environment that would utilize my overall abilities, knowledge, skills in taking up responsibilities entrusted upon me by the Company and also which will help my career to grow in prosperous manner.

WORK EXPERIENCE :
Four Year working experience in Torrent Pharmaceutical Limited as a Medical Representative at Jaipur.
Three month working experience in Piramal Healthcare Ltd. as business executive at Jaipur HQ.

ACHIEVEMENTS :
North India Topper in Veloz-D, Pregalin-x
All India Topper in Gemitrol

EDUCATIONAL QUALIFICATION :
Secondary Rajasthan Board, Ajmer , with 62%
Sr. Secondary Rajasthan Board, Ajmer , with 67%
B.Pharma Rajasthan University, Jaipur , with 67%
M.Pharma (Result awaited ),
Jaipur National University,
Jaipur.

TECHNICAL QUALIFICATION :
Operating System : DOS, Windows’98
Application Tools : Ms-Office, Internet

INDUSTRIAL TRAINING & PROJECT :
Industrial Training done in 2003 with Rajasthan Drug & Pharmaceutical Limited at Jaipur in B.Pharma (IIIrd year)
Project Work done on Low Molecular Weight Heparin in B.Pharma (Final year)
Project work done on Dossier requirement for herbal product for submission in United state and European market.

PERSONAL PARTICULARS :
Name : Mahendra Kuril
Father’s Name : Sh. M.P. Kuril
Date of Birth : 18/05/1981
Nationality : Indian
Sex : Male
Marital Status : Married

Date :
Place : (Mahendra Kuril)

[bsingh.pharm@gmail.c]

CURRICULUM VITAE
Bhupinder Singh
e-mail : bsingh.pharm AT gmail.com

Career Objective :
To seek a challenging and responsible position in an institution requiring strong analytical, conceptual and organizational skills.

Summary :
Excellent analytical, organizational and communication skills. Hard working, Team Player, Knowledge of work and experiment design.

Educational Qualification :
Present Position :
Pursuing M. Pharmacy - Pharmacology, registered on 11th July 2007 on the Topic “Studies on neuropharmacological properties of Passiflora Incarnata Leaf Extract” under the supervision of Dr Rajesh Kumar Goel, Reader, Dept. of Pharm. Sci. & Drug Res., PunjabiUniversity, Patiala.
Thesis submitted.

Field of specialization : CNS activity of plant extract.

Hands on Expertise :
Good Knowledge of computer software such as Sigma stat and MS Office (MS-Word, Excel and PowerPoint). Knowledge of latest laboratory equipments i.e. handling, operation etc., Experimental Animals Handling, In vivo (experimental) ; Clinical research; Experience on Medicinal Plants in vitro and in vivo experiments, Antioxidant assays, UV/Visible Spectrophotometer, Auto-analyser, Thin layer chromatography, HPLC, spectroflurimetry, biochemical assays like Estimation of serotonin, nor epinephrine, protein, assessment of hippocampal atrophy etc. Clevenger & Soxhlet apparatus, Phytochemical screening of crude drug, Macro & microscopic characterization of crude drug.

Knowledge of Computers :
MS-OFFICE (MS-WORD, MS-EXCEL, MS-POWERPOINT)

Major Programme Studied :
Pharmacology, Biopharmaceutics, Human Anatomy and Physiology, Microbiology, Immunology, Biochemistry, Food Biochemistry, Fermentation Technology, Chemistry, Molecular Biology, Bio-Organic Chemistry, Biotechnology, Enzymes and Metabolism I & II, Medical Biochemistry, Bio-analytical Techniques, Cell Biology, Computational Techniques, C ++, Mathematics and Statistics, Marketing and Hospital Management, Forensic Science.

Achievements :
Got Distinction in various subject during matriculation
Got Distinction in National Olympiad of Mathematics.

Qualified GATE 2007 (IIT, Kanpur) : AIR 1462
Presented a research paper entitled 'Dual Protective Effect Of Passiflora incarnata Leaf Extract’ and won 2nd prize at national conference on innovations in drug discovery and research held at PunjabiUniversity , Patiala in March-2009.
Published research article on antiepileptic activity of Ficus religiosa.
Communicated two research papers on “studies on Neuropharmacological properties of Passiflora incarnata”.c

[Guest]

CURRICULUM VITAE
Mr. VISHAL ANTIL
Email :vishalantil AT gmail.com

Personal Data :
Born on : 21st September, 1983
Marital status : Unmarried
Nationality : Indian
Languages known :
English
Hindi

I am :
Looking for a position in a result-oriented research organization where acquired skills and education will be utilized towards continuous growth and advancement and also provide opportunity to learn new technologies.

EXPERIENCE :
16 months teaching experience in G.V.M. College of Pharmacy, Sonepat

MY EDUCATION :
M. Pharm. [Pharmacognosy] B.R. Nahata college of Pharmacy, Mandsaur (M.P.) securing 71.21%.
B. Pharm. Hindu college of Pharmacy, Sonepat (Haryana) securing 71.32%.
Online certificate course in Intellectual property Rights from W.I.P.O securing 83% marks.
Post graduate diploma in Drug regulatory affairs from Jamia Hamdard University, New Delhi.
Senior secondary from C.B.S.E. Board securing 70.00%.
Higher secondary from C.B.S.E. Board securing 73.60%.

EXPOSURE TO COMPUTER :
Internet, Excellent in Application software Microsoft Office
Graph Pad Prism 4.0.

M.PHARM PROJECT :
Title : “Development of Herbal Formulation of Viola odorata Linn.” Under esteemed supervision of Mr. Amit
Kumar Jain (Lecturer), Department of Pharmaceutics, B.R. Nahata college of Pharmacy, Mandsaur (M.P.).

PRESENTATION AND PAPER COMMUNICATED :
Herbal Immunomodulators, poster presented in 2nd National Seminar & Intellectual Property fair on Green Pharmacy, organized by Contract Research Center, B.R. Nahata College of Pharmacy – SIRO, Mandsaur, MP.
Extracts and molecules from medicinal plants against Herpes simplex virus, poster presented in 2nd National Seminar & Intellectual Property fair on Green Pharmacy, organized by Contract Research Center, B.R. Nahata College of Pharmacy – SIRO, Mandsaur, M.P.
Role Of Plants In Hypertension, poster presented in 2nd National Seminar & Intellectual Property fair on Green Pharmacy, organized by Contract Research Center, B.R. Nahata College of Pharmacy – SIRO, Mandsaur, MP.
Aloe Vera , poster presented in 2nd National Seminar & Intellectual Property fair on Green Pharmacy Contract Research Center, B.R. Nahata College of Pharmacy – SIRO, Mandsaur, MP.
Studies On Timed Release (SR) Granules Of Aceclofenac By Using Different Concentration Of Sodium Carboxy Methyl Cellulose, poster presented in National seminar on emerging trends in drug discovery and formulation development, J.C.D.M. College, Sirsa, Haryana.
Pharmacognostical and Phytochemical evaluation of Viola odorata, poster presented in National seminar on emerging trends in Pharmaceutical sciences, Jamia Hamdard University, New Delhi.
Development and In Vitro Characterization of Time Controlled Release Tablet of Salbutamol, poster presented in International conference on Innovative technologies, P.D.M. College of Engineering, Bahadurgarh, Haryana.
Study Of Novel Ibuprofen Prodrugs With Reduced Gastric Damage, Improved Analgesic And Anti Inflammatory Effects In Rodents, poster presented in International conference on Innovative technologies, P.D.M. College of Engineering, Bahadurgarh, Haryana.
Development Of Time Controlled Release Tablet Of Nifedipine For Safe And Accurate Targeting In Angina Pectoris, poster presented in International conference on Innovative technologies, P.D.M. College of Engineering, Bahadurgarh, Haryana.
Anticonvulsant Activity of Nerium indicum, poster presented in International conference on Innovative technologies, P.D.M. College of Engineering, Bahadurgarh, Haryana.
Hodgkins Disease and Its Management : a Review, 9th annual conference of society of Pharmacovigilance India, Rajendra institute of Technology and science, Sirsa, Haryana.
Diuretic, laxative and toxicity studies of Viola odorata aerial parts, original research paper published in Pharmacologyonline 1 : 739-748 (2009).

WORKSHOP/ CONFERENCE ATTENDED :
3rd National Seminar & Intellectual Property fair on Green Pharmacy.
3rd National seminar on Drug discovery and drug development.
2nd National Seminar & Intellectual Property fair on Green Pharmacy.
Academia-Industry Seminar on “Chinese & Canadian Experiences in Pharmaceutical Research” organized by Contract Research Center, B.R. Nahata College of Pharmacy SIRO, Mandsaur, M.P.
Academia-Industry Workshop held on Contract Research Center, B.R. Nahata College of Pharmacy SIRO, Mandsaur, M.P.
60th Indian Pharmaceutical congress, 2008 held at Netaji Subash Institute of Technology, New Delhi.
International conference on Innovative technologies, P.D.M. College of Engineering, Bahadurgarh.

TECHNICAL SKILLS AND ABILITIES :
ANALYTICAL INSTRUMENTS :
HPLC System, Infra Red Spectrophotometer, UV Spectrophotometer, flame photometer.

BIOLOGICAL EVALUATION :
Analgesic, Diuretic, Laxative. C.N.S. and Anti-asthmatic activity.

ANTIMICROBIAL ACTIVITY :
Disc Diffusion Method.

ANTIOXIDANT ACTIVITY :
D.P.P.H Method.

REFERENCES :
Dr. Anupma Diwan
Head of Department
Dept. of Pharmaceutics,

Mr. Jitesh Katewa
General Manager
Unisule Pharmaceuticals Pvt. Ltd.

I hereby declare that information given is true to my knowledge.

Place : Sonipat.
Date :

Yours sincerely,
(Vishal Antil)

[Unregistered]

CURRICULUM VITTAE
MONIKA
Email Id : monika7027 AT gmail.com

CAREER OBJECTIVE :
To work in a challenging and creating environment where I can utilize my current knowledge, skills and education towards achievement of personal and organizational goal.

SALIENT QUALITIES :
Ability to do work under strict deadlines without compromising with quality of work.
Adaptabilitysuits to every work environment.
Positive attitude with trust and integrity.
Optimistic & believe in teamwork.

KEY-SKILLS :
Have good Knowledge to operate UV/Visible Spectrophotometer, FTIR, Disintegration Apparatus, Dissolution Apparatus, Roche Friabilator, Thin Layer Chromatography and a good practical hand.
Good in handling of Laboratory equipments and Analytical Instruments.
Good in practical and experimentation.

PROFESSIONAL QUALIFICATION :
EXAM / DEGREE YEAR OF PASSING NAME OF INSTITUTE UNIVERSITY / BOARD SCORE
M.PHARMACY (2nd year)
M.PHARMACY
(1st year) Pursuing (2013)
2012
CHANDIGARH COLLEGE OF PHARMACY, LANDRAN, MOHALI
PUNJAB TECHNICAL UNIVERSITY, PATIALA
71.01%
B.PHARMACY 2011 M.M. COLLEGE OF PHARMACY, MULLANA (AMBALA) M.M. UNIVERSITY, MULLANA (AMBALA) 71.88%

EDUCATIONAL QUALIFICATION :
ACADEMIC QUALIFICATIONS :
EXAM / DEGREE YEAR OF PASSING NAME OF INSTITUTE UNIVERSITY / BOARD %AGE OBTAIINED
12TH 2006 GGMSS School sec-8, CHD CBSE 68.2%
10th 2004 GMH School sec-12 CHD CBSE 63.6%

PROFESSIONAL MEMBERSHIP :
Duly registered as registered pharmacist in Haryana State Pharmacy Council, Panchkula (Haryana), INDIA.
FIELD OF SPECIALIZATION : M.Pharmacy (Pharmaceutics)
ACHIEVEMENTS
Participated in Rangoli competition in “Jalsa Youth Festival-2010” sponsored by Dainik Bhaskar and Healthyway Immigration Consultants, held at Parade Ground, Sec-17,
Chandigarh.

COMPUTER SKILLS :
Proficient in Microsoft Windows 98, 2000, XP, 2007, Microsoft Office Suite (Word, Excel, PowerPoint and Access), Internet & X-Pharma.
Scientific Information Retrieval using search engines like Science Direct, Pub med, Scirus, Informa Healthcare, Google Scholar.

INDUSTRIAL TRAINING :
One month Industrial Training in orals, Tablet, Capsule, Q.C. and Documentation at Indian Pharmaceutical and Allied Industries, Panchkula (Haryana) from 11th June 2009 to 11th July 2009.

FINAL YEAR RESEARCH PROJECT :
Pursuing Project on “Microparticles drug delivery system for sustained release ” during 2nd Year of M. Pharmacy.

PROJECT SUMMARY :
Microparicles as novel drug delivery system in the form of free flowing powder or liquid droplet coated with a suitable polymer. These have particle size in microns ranging from 0.1µm-200 µm which provides the sustained and controlled drug delivery for a long period of time and are used to improve the efficiency of drug delivery systems. Various biocompatible and biodegradable polymers from natural and synthetic origin have been utilized to prepare microparticles of desired properties. The approach of using microparticles as a drug delivery system is a reliable mean of delivering drug in proper concentration to the target site at a pre-determined rate. So the effectiveness of therapy get improves specially in case of anti cancer drugs and other organ targeting therapy. The surface area of microparticles being very large, there loading capacity is very high so the amount of drug release is also high. The properties of microparticles can easily be modified according to requirement by coating them with a polymer of desired characters to control release of drug. The microparticles are evaluated for their size, shape, entrapment efficiency; % drug entrapped, drug release profile and stability.

AREA OF INTEREST :
Regulatory Affairs
Pharmacovigilence
Quality Assurance

PULICATIONS AND POSTER PRESENTED IN NATIONAL/INTERNATIONAL SEMINARS/ CONFERENCES :
1. Monika, Jitendar Madan, “Medicated Tattoos : A New Transdermal Drug Delivery System” 16th Feb. 2013, National Conference on Future Focus on Achieving Excellence in Pharmacy Education & Research.
2. Vikas Jhawat, Vipin Saini, Shah Asma, Monika, “A novel drug delivery-Transdermal Systems” AICTE sponsored International Conference on Current & Future Scenarios in Drug Development & Delivery, August 11-12 (2012), JCD College of Pharmacy, Sirsa (Haryana).

CONFERENCES/ SEMINARS ATTENDED :
1. National Seminar on Recent Advances in Oral Controlled Drug Delivery System October 1, 2011 Organized by Amar Saheed Baba Ajit Singh Memorial College of Pharmcy, BELA (Ropar) in Collaboration with Punjab Technical University, Jalandhar.
2. One Day Seminar on Quality Aspects of Solid Dosage Forms 19th January, 2013 Organised by SMPIC, NIPER.
3. One Day Workshop based on “Analytical Techniques for Research in Pharmacy” held at M.M. College of Pharmacy, M.M University, MullanaAmbala on7th December, 2012.
4. National Conference on “Future Focus on Achieving Excellence in Pharmacy Education & Research” held at Ganpati’s Group of Institutions, Bilaspur, HP, on 16th Feb. 2013.
5. National Seminar on Global Scenario of Pharmaceuticals, Challenges and Regulatory Policies held at Himalayan Institute of Pharmacy, Kala-Amb (H.P) on 2nd March, 2013.

INTEREST & HOBBIES :
Listening to music
Watching movies
Cooking food
Watching Cricket

PERSONAL DETAILS :
Father’s name Sh. Dharamvir singh
Date of Birth – June 28, 1988
Marital Status – Single
Nationality – Indian
Languages Known – English, Hindi, Punjabi

DECLARATION :
Hereby I declare that the information given above is true to the best of my knowledge.

Place :
Date :
Monika

[Unregistered]

Mokireddi Alekya
(B. Pharm, M. Sc. Pharmaceutical Regulatory Affairs)
Email ID : alekyapharma11 AT gmail.com

Objective :
To perform the task assigned to me with the best of my ability and to work dedicatedly towards the success of the organization and trying my best for the respect of organization where I can broaden my knowledge base and professional skills in a suitably challenging role. I am keen to achieve further professional development.

Area of interest :
Pharmaceutical Regulatory Affairs
IPR

Educational qualifications :
Qualification Institution University / Board Year % :
Masters in Pharmaceutical Regulatory Affairs Part II Manipal College of Pharmaceutical Sciences (M.C.O.P.S), Manipal. Manipal University. July 2013 Awaiting for results
Masters in Pharmaceutical Regulatory Affairs Part I Manipal College of Pharmaceutical Sciences (M.C.O.P.S), Manipal. Manipal University. June 2012 78.1
B. Pharm St. Ann’s College Of Pharmacy, Visakhapatnam Andhra University May 2011 91.20
D. Pharm Yalamarty College Of Pharmacy, Visakhapatnam State Board of Technical Education April 2008 83.00
10+2 Vikas Junior College, Visakhapatnam Board of Intermediate Examination, A.P. April 2006 77.77
X Rama Krishna Residential Public School, Visakhapatnam SSC Board. April 2004 81.33

In-house seminars delivered :
1. Drug regulatory authorities in India.
2. Annual product quality review.
3. Virtual Clinical Trials.
4. Schedules of Drugs and Cosmetics Act.
5. Drug Price Control Order.
6. Clinical Data Management.
7. Quality guidelines.
8. Hatch Waxman Act
9. Scale up procedure post approval changes (SUPAC)
10. NDA, IND review process
11. Regulatory concerns of PAT
12. ASEA harmonization & drug regulations
13. Good warehouse practices
14. Design of clinical trials
15. BA BE guidelines of different countries

Industrial training :
** Have undergone training for 1 month in UNIMARK REMEDIES, Gujarat and learnt DMF filing requirements for different regulatory authorities.
** Have undergone industrial training for 45day in MATRIX LABORATORIES, Pravda, Visakhapatnam.
** Have done training for 3 months as trainee pharmacist in KING GEORGE HOSPITAL, Visakhapatnam.

Achievements :
** Participated in Conventus GITAM Pharma Fest 2009. (Poster presentation)
Topic : Chemotherapeutic role of potential COX II inhibitors.
** Participated in IPC (India Pharmaceutical Congress) 2011. (Poster presentation)
Topic : Highly Variable Drugs –Regulatory Aspects
** Participated in Idola Pharma Fest 2011. (Poster presentation).
Topic : Alzheimer’s disease.
** Participated in IPA (Indian Pharmaceutical Association) 2012.
** Was selected as Best Acedamic Student in D. Pharm 2008.
** Got distinction in B. Pharmacy.
** B.A Correspondence (Public Administration, Sociology, Politics)
** PG Diploma in Software engineering (Microsoft office, C language, C++ language, Oracle, MS. Net, Testing Tools )
** Participated in Pharma- OMICS 2012. (Poster presentation)
Topic : Regulatory framework and market access of generic medicines in the European Union

Extracurricular activities :
** Listening to music, painting, watching cricket, surfing internet, reading blogs

Computer knowledge :
** Microsoft word, Microsoft excel, Microsoft power point, Internet applications.

Knowledge areas :
** Familiar with various Regulatory Guidelines (ICH, FDA, EMEA, CDSCO, etc.).
** Knowledge of Code of Federal Regulations.
** Registration of New Drugs and Generics in India, US, Europe, ROW etc.
** Common technical Documents (CTD)-filing.
** Dossier preparation for various Dosage Forms.
** DMF filling.
** Electronic submissions.
** ACTD submissions
** GMP regulations- WHO, US, Europe.
** Pre & Post Marketing Regulatory Requirements.
** Response to Warning Letters.
** Intellectual Property Rights.
** Clinical Trials & Regulations.
** Nanobiotechnology.
** SOPs, OOS, and Change control procedures.
** Handling UV-Visible spectrophotometer.
** Handling of dissolution apparatus.

Live Projects :
“Regulatory requirements for filing Generics in Emerging markets.” (6 months). Worked as a project trainee in HETERO DRUGS, Hyderabad. Learnt submissions for different regulated (US, EU), semi regulated markets and did generic filings for Africa and ASEAN countries.

Personal Profile :
Name : MOKIREDDI ALEKYA
Father's Name : RAMA KRISHNA
Mother's Name : SUBHASHINI
Nationality : Indian
Date of Birth : 25/11/1988
Marital Status : Single
Languages Known : Telugu, Hindi and English.

Declaration :
I authorize that the information furnished above is true to the best of my knowledge and belief.
Place :
Date : Signature
(MOKIREDDI ALEKYA)

[miqubal]

CURRICULUM VITAE :
Murteza Iqubal
Mail : murteza5 AT rediffmail.com

CAREER OBJECTIVE :
To work for the challenging assignment that will provide me the opportunity to put my abilities towards growth in the respective field.

EDUCATION :
Bachelor of Pharmacy , June 2010 From Jamia Hamdard,New Delhi62
M.Pharma ,june2012 From Jamia Hamdard, New Delhi

SKILLS :
Hard working, reliable and punctual.
Honest Dependable Excellent interpersonal skills.
Team oriented Organized Manage time well.
Project Coordination & Thorough Tactful.

COMPUTER KNOWLEDGE :
Working knowledge of MS Office (Word, Excel, and Power point), and Internet Explorer.

ACADEMIC RECORD :
SR. NO Examination School/College /University Board/University Year of Passing % Obtain or Grade :
1. Master of Pharmacy From Jamia Hamdard With 71.83%,CGPA(8.18)
2. Bechlor of Pharmacy From Jamia Hamdard With 59.80% 3. Senior Secondary Education Govt. Senior Secondary School, Patna ,Bihar Board of secondary Education, Bihar,Patna 2001 83.20
4. Secondary Education Govt. Senior Secondary School, Bihar Board of secondary Education, Bihar,Patna 1999 55.50

AREAS OF INTEREST :
Pharmacovigilance
Clinical research associate
Clinical Data Analyst
Bioavailability & Bioequivalence
Intellectual Property Rights
Drug Regulatory Affairs
Quality Assurance

INSTRUMENTS HANDLING EXPERIENCE :
HPLC
HPTLC
GCMS
UV Visible Spectrophotometer

SEMINARS :
A seminar Presented a Poster on “The Isolation and Structure Elucidation of Different Phyytoconstituent from Artocarpus heterophyllus with Antidiabetic Activity Against Streptozotocin Indiced Diabeties in rats at APA INTERNATIONAL CONGRESS ON ADVANCED IN HEALTHCARE INDIA 2012 New Delhi India
A seminar Presented a Poster on “Development of low Citrinine containing Monascus pigment produced by solid state fermentation of rice with Monascus perpureus at INTERNATIONAL CONFERRENCE OF MICROBIAL BIOTECHNOLOGY FOR SUSTAINABLE DEVELOPMENT SCHOLARSHIP AWARD :
QUILIFIED GPAT With 88.22 Percentile(32.33%) in the Year of 2010
The scholarship awarded by Sir Ratan Tata Trust, Mumbai in 200809 & 201011.

PROJECT WORK :
M.Pharm Project : “Studies On Biosynthesis of Menaquinone7 by Bacillus Subtilis MTCC 2756 Under Different Fermentation Condition

[Unregistered]

SNEHA RANJAN C/O Mr. Y. Prasad
Email : sneha.ranjan11 AT gmail.com

OBJECTIVE :
“To use my knowledge and skills in best possible way for the betterment of environment that can encourage my learning and creativity, provides an exposure to new ideas and stimulate personal and professional growth”.

CURRENT STATUS :
Presently working as Consultant for Drug Regulatory Affairs in Accredited Consultant Pvt. Ltd., Mayur Vihar, since 2011.

SUMMARY OF QUALIFICATION :
M.Sc. Biotechnology from Allahabad Agriculture Institute, Allahabad in 2005

CAREER SUMMARY :
More than 6 yrs of working experience in the field of Quality Control, Analytical Testing and Drug Regulatory Affairs

PROFESSIONAL EXPERIENCE :
Working as Consultant for Drug Regulatory Affairs in Accredited Consultant Pvt. Ltd., Mayur Vihar, since 2011.ACPL is involved in providing Consultancy Solutions for Drug Regulatory, Accreditation, Custom Duty and Clearance

PROFILE :
Preparation, Technical Evaluation and Submission of the Dossiers and Flies for the Registration of Drugs, Medical Devices and Diagnostic kits
Technical Evaluation and Submission of the Dossiers and Flies for the Import License of Drugs, Medical Devices and Diagnostic kits
Technical Evaluation and Submission for the Test License of Drugs and Diagnostic kits
Technical Evaluation and Submission for Clarification and NOC of Drugs, Medical Devices and Diagnostic kits
Technical Evaluation and Submission for the approval of new drugs and clinical trials/Field Trials
Provide guidance and Submission for the Grant of Personal License, NOCs for Export
To provide guidance in getting Food License, BIS Certification and DGFT
To provide consultancy in getting Local Drug License
To handle various regulatory clarifications and queries

Clients Handled : Alere Medical Pvt. Ltd. India, Johnson & Johnson, Pfizer Animal Health India Ltd., Baumer S.p.A., Safe & Simple, Cochlear, M.I.Tech, Vemedim, Argon Critical Care System, M.P. Biomedicals, Xema Ltd. Co., Allied Biotechnology India Pvt. Ltd., etc

The Products Handled : Knee & Hip Implant System, Stents, Catheters, Dental Implants, Diagnostic Kits, Finished Formulations and APIs.

Worked as Senior Analytical Chemist in Bureau Veritas Consumer Products Services Pvt. Ltd., Noida. A French MNC Company involved in service providing & testing under SHEQ (having NABL Accrediated lab), from Dec.,2008 to May 2011

PROFILE :
Testing as per method & documentation
Full conversant with the test methods that are performed in the analytical division.
Calibration of testing instruments & taking care of their maintenance as and when required.
Proper maintenance of the record as per GLP.

Worked as Q.C. Analyst in J. Mitra & Co. Pvt. Ltd., New Delhi, provides specialized services
Medical, Industrial, Laboratory equipment & Manufacture of Diagnostic kits and Reagents, from
Jun., 2006 to Dec., 2008

PROFILE :
QC testing & analysis of inprocess, raw material & finished product.
Calibration & validation of instruments and method respectively
Documentation
Coordination with other department
Complain handling (if any)

EDUCATIONAL QUALIFICATION :
M.Sc (Biotechnology) from Allahabad Agriculture Institute –Allahabad with 82.7% marks in the year 2005.
B.Sc Biotechnology (Hons.) from Ranchi Women’s College, Ranchi University with 65.85% marks.
Senior Secondary Certificate Examination 12th from Kendriya Vidayalaya, C.B.S.E. with 55.4% marks

PROJECTS AND TRAININGS :
Worked as a trainee in Panacea Biotec Ltd. (R&D), New Delhi, on Polysaccharide vaccine as a
part of Biotech Industrial Training Programme (BITP) sponsored by Biotech Consortium
India Ltd. (BCIL) form Nov. 05 to May 06.

“Evaluation of the characteristics and performance of AURO – TB – PCR for the diagnosis of
Tuberculosis in comparison to BACTEC Culture and ZN Staining” under the supervision of
Dr. Neeraj Goel, Technical Head, Auroprobe Laboratories, New Delhi.

“Clonal Propagation a Tool of Biotechnology” under the supervision of Dr.Sandhya Sinha,
Department of Botany, Ranchi Women’s College, Ranchi.

Attended a Summer Training program in the Department of Microbiology, Clinical Biochemistry,
Serology and Hematology at Indira Gandhi Institute of Medical Science, Patna.

COMPUTER SKILL :
Diploma in Computer application (6 months)

PERSONAL DETAILS :
Date of Birth : 11th Sep. 1979
Father’s Name : Mr. Y. Prasad
Nationality : Indian
Language Known : Hindi, English & Bengali

Date :
Place : Ghaziabad

(SNEHA RANJAN)

[Unregistered]

CURRICULUM VITAE
PRACHI PRAVA MISHRA
Email : prachipravam.pharma AT gmail.com

OBJECTIVE :
To work in a professional & competent atmosphere that enables me to cope with the emerging technologies there by broadening the spectrum of my knowledge and talents to achieve professional satisfaction and growth of the company with proper contribution towards the goals of the organization.

JOB DESCRIPTION :-
The Core Area of Working Exposure is Drug Regulatory Affairs – Formulation.
Responsibilities :-
** Compilation of technical data required for filing purpose through eCTD in WHO, PEPFAR, US, EUROPE & ROW.
** Ensuring timely availability of Quality Documents including Registration Samples for submission purpose.
** Technical Review & Approval of Master as well as Executed Documents to ensure compliance with International as well as domestic regulations and standards.
** To provide the required information/documents/samples to respond the deficiencies received from regulatory agencies.
** Artwork review and approval.
** Approval of Protocols, Change Controls & Deviations.
** To provide technical documents for applying LOP/LUT and to keep its tracking.
** Tracking of all the data like shelf-life, API source, Approval status of all the products under WHO, PEPFAR, US, Europe and ROW.
** Have good knowledge regarding Preparation of Dossier.
** Partially involved in Licensing activities – Verification of Manufacturing Licences, Test Licences etc. To ensure generation of COPP & Manufacturing licence in line with country regulatory & customer requirements.
** Additionally also take care of Training, training related documents, SOPs.

Audits :-
Supported Regulatory Agency inspection at site like WHO, USFDA, MHAZ, Tanzania etc.

PROJECTS HANDLED :
** ARVs – LNZ 30/50/60 mg, Efavirenz Tablet 600 mg, Nevirapine Tablet 200 mg, Nevirapine ER Tab 400 mg, Tenofovir DF Tab/Lamivudine Tab 300/300 mg, Lamivudine Zidovudine Dispersible Tablet 30/60 mg and many more.
** Non ARVs – Eletriptan Film coated Tablet, Omeprazole DR Capsules, Lisinopril Tab, Lisinopril Hydrochlorothiazide Tablet etc.
** Market : WHO, US, Canada, EU, Pepfar, ROW

EDUCATIONAL QUALIFICATIONS :
Degree Board/University Percentage Class Year of pass :
M. Pharm. (Pharmaceutics) Utkal University , Vani Vihar, Odisha 84.00 % First Class (Distinction) 2011
B. Pharm. Utkal University , Vani Vihar, Odisha 80.00 % First Class (Distinction) 2009
H.S.E. Council Of Higher Secondary Education , Odisha 73.00 % First Class 2004
H.S.C. Board Of Secondary Education, Odisha 84.00 % First Class 2002

TRAINING UNDERATAKEN :
6 months experience in Glenmark Pharmaceutical Lab, R&D, Sinnar, Maharastra in Formulation and Development as a project trainee for the partial fulfilment of Master of Pharmacy in Pharmaceutics.

ACHIEVEMENTS :
** Qualified in GATE 2009, IIT, Roorkee with 94 percentile.
** Qualified in GPAT (Graduate Pharmacy Aptitude Test) , 2010.
** N.R.T.S. in 5th & 7th standard and rank holder in state label talent scholarship.
** Award of Rajyapuraskar(Governor Certificate) as a Guide and attended many camps.

PAPER WORK :
** Development of “UV Spectroscopic method of analysis of Stavudine in bulk and pharmaceutical dosage form” has been published in Pakistan Journal.

** Development of “UV Spectroscopic method of analysis of Lornoxicam in bulk and pharmaceutical dosage form” has been accepted for publication in IJPS.

COMPUTER PROFICIENCY :
Windows, MS Word , MS Access , MS Excel , MS Power Point , Internet Surfing.

AREA OF INTEREST :
Drug Regulatory Affairs, Pharmacovigilance

PERSONAL SKILLS :
** Take joy in working in a group with leadership qualities.
** Ability to meet given deadlines
** Lucidity of thought.
** Adaptable and amiable
** Initiative capability to be a 'self starter'

PERSONAL DETAILS :
Father’s Name : Mr. Gagan Bihari Mishra
Nationality : Indian
Religion : Hinduism
Date of Birth : 8th Jan,1987
Marital status : Married
Languages Known : English, Hindi, Odia, Marathi

DECLARATION :
I hereby declare that all the statements made in above application are true and any discrepancy found in above information will render me liable for cancellation of my candidature at your esteemed organization.
Prachiprava Mishra