1. CURRICULUM VITAE
SAURABH AGRAWAL Address: B-74, Street No. 10, Shashi Garden,
Mobile No.:- +91-9891599048 New Delhi.
Email : sauagr2@gmail.com
CAREER OBJECTIVE
Seeking an opportunity to be a part of an esteemed organization and contribute my regulatory
skills and specialized knowledge to the success of the organization thereby nurturing myself
intellectually and professionally.
PROFESSIONAL EXPERIENCE
1- Regulatory Affairs Consultants:-M/s Accredited Consultants Pvt. Ltd., New Delhi from
Jan 2015 to till date.
2- Regulatory Affairs Executive:- M/s Asmoh Laboratories Limited, Noida from Oct 2013
to Dec 2014.
3- Production Chemist:-Inject care Parenterals, Vapi, from June 2013 to Oct 2013.
CAREER INTEREST
Drug Regulatory affairs
WORK PROFILE
1-Import/Indian Regulations:-
A. CDSCO
- New Drug Approval (Form 45/46)
- Registration (Form 41) for Medical device, Drug and Diagnostics Kits
- Registration (Form 42) for Cosmetics
- Import License (Form 10)
- Import Test License (Form 11)
- COPP for Ayurvedic Products
B. Zonal FDA
- No Objection Certificate for Export and Import
- Test Manufacturing License NOC
C. State FDA
- Test Manufacturing License (Form 29)
- Wholesale and Retail drug License (20B, 21B and 20, 21)
D. FSSAI
- Food License for Import, Manufacturing, Retail, Wholesale and Distribution.
2-Export Regulation:-
-Compilation, and successfully submissions of drug regulatory dossiers in CTD &
ACTD format. i.e. Myanmar, Cambodia, Philippines, Benin, Cameroon,
Burkina Faso, Senegal, Guatemala & Hondurous.
-Prepare and compile of Analytical Method Validation and Process Validation for
Pharmacopoeial and Non- Pharmacopoeial Products.
2. - Review and finalize the carton artwork for samples and commercial shipments.
-Excellent hand in solving queries of the dossier received from various countries.
-Documents review such as SMF, BMR, PDR, PVR, CDP, COA & Stability study.
-Legalization of documents from embassy.
ACADEMIC PROFILE
Degree College Percentage Year
M. Pharm. B.R Nahata College of pharmacy Mandsaur 80% 2013
.
B. Pharm. Rajiv Academy for Pharmacy Mathura 67% 2011
EXTRA CURRICULAR ACTIVITIES
GPAT Score 93 percentile 2011
COMPUTER PROFICIENCY
Well conversant with Microsoft office (MS-word, MS-excel & MS-power point)
PERSONAL PROFILE
• Nationality Indian
• Father's name Mr.Parmanand Agrawal
• Gender Male
• Marital status Married
• Language English, Hindi
• Strengths Fixed determination, Confident, Good
learning ability.
• Permanent Address Main Market Gursarai, Dist- Jhansi
(U.P)
I hereby solemnly declare that all the information provided here is as per the best of my
knowledge. If chance is given to me, I assure you that, I will prove myself as an asset to your
organization.
Place: New Delhi Saurabh Agrawal