1. PRIYANK SRIVASTAVA
Contact: +91- 8882524228, +91-9625364839
E-mail: priyanksrivastva@gmail.com
REGULATORY AFFAIRS PROFESSIONAL
Seeking a challenging and rewarding management position in the field of Regulatory Affairs to help the company in
achieving quality objectives & growth and earn job satisfaction & recognition.
PROFESSIONAL EXPERIENCE
Designation: Regulatory Affairs Specialist. May 2012 to Present
Company Name: Accredited Consultants Private Ltd., Delhi.
Company Profile: Complete Regulatory Consultancy service provider for Drugs, Medical Devices, Diagnostic Kits,
API’s, Cosmetics and Food Products etc. (www.acplgroupindia.co.in)
Designation: Quality Assurance & Quality Control Head. May 2010 to April 2012
Company Name: Real Chemsys Products (P) Ltd, Noida.
Company Profile: Fine Organic & Inorganic chemicals, Intermediates, HPLC & Dried/ Anhydrous solvents and
Laboratory reagents, Stains & Indicator manufacturer. (www.realchemsys.com)
CORE COMPETENCIES
 Professional service mentality – willing to go beyond the call of duty to satisfy their clients.
 Commitment to highest quality outputs, including obsessive attention to detail.
 Enthusiasm and pro-activity.
 Team collaborators, ability to be successful working in team.
KEY RESPONSIBILITIES AS REGULATORY AFFAIRS SPECIALIST
 Ensure professional planning with High proficiency, full regulatory compliance with all regulations, codes and
standards for efficient registration of Medical Devices, Diagnostic Kits, Drugs and Cosmetics.
 Review and Compilation of Applications and Registration dossiers & Master documents etc., Responsible for
sustaining excellent standards of the regulatory documents through comprehensive reviews.
 Develop and execute regulatory plans for complex projects, new registrations and maintenance of existing
licenses.
 Contribute to special assigned activities and projects, or represent Regulatory Affairs in cross-
functional assignments and projects. On-site Regulatory Services for Medical Devices and Diagnostics.
 Review and Development of artworks & labeling as per requirements of Drugs & Cosmetic Act Rules (Rule 96).
 Review & approval of Promotional Material and Patient Information Leaflets.
 Handling deficiencies arising from Regulatory Authorities and resolving the queries as requested by the
Customers and Regulatory Agencies.
 To co-ordinate and provide periodic update of the interactions with drug authorities for the registration/renewal of
certificates and Responses to Health Authorities queries.
 To prepare the prescribing information and abbreviated prescribing information for the products.
KNOWLEDGE AND SPECIALIZATION:
 Specialization in Medical devices specially Orthopedics, Cardiac and Dental Implants with other Devices.
 Worked with Class II and Class III devices extensively.
 Sound knowledge of ICH guidelines; CTD: Module 1 to Module 5.
 Submission requirements of various markets such as USFDA, EMEA, Emerging/ROW etc.
 Maintain knowledge and understanding of regulatory requirements in region of responsibility Developing
Regulatory Strategy, Regulatory Compliance and Training to team.
 Exposure in basics of ICH-GCP, ICMR guidelines, GMP, Schedule Y, Drugs and Cosmetics act and rules 1940.
WORK PROFILE INCLUDES:
Drugs & API’s:
 New Drug Approval’s (NDA and ANDA Filings), Registration, Import License from Central Drug Standard
Control Organization New Delhi (CDSCO).
 Test License, No Objection Certificates for export, CoPP Applications etc. from Zonal FDA.
 Free Sale Certificates, CoPP, Manufacturing License, Manufacturing Permissions, WHO GMP, Warehouse
License from State FDA.
Biologicals:
 New Drug Approval, Registration, Import License from Central Drug Standard Control Organization New Delhi
(CDSCO)
 Clinical Trial Permissions from Indian Council of Medical Research (ICMR), New Delhi
 Permissions for Import & Export of Biologicals from Indian Council of Medical Research (ICMR), New Delhi

2. PRIYANK SRIVASTAVA
Contact: +91- 8882524228, +91-9625364839
E-mail: priyanksrivastva@gmail.com
 R&D Approval from Department of Science and Industrial Research (DSIR).
Medical Devices & IVD’s:
 New Devices Registration (NDA Filing), Registration, Import License from Central Drug Standard Control
Organization New Delhi (CDSCO).
 Test License, No Objection Certificates for export etc. from Zonal FDA.
 Free Sale Certificates, CoPP, Manufacturing License, Manufacturing Permissions, WHO GMP, Warehouse
License from State FDA.
 On-site Regulatory Services for Medical Devices and Diagnostics.
 Equipment Type Approval and Import License for the wireless devices viz. Cardiographs and Monitoring Devices
from Wireless Planning & Coordination Wing, Department of Telecommunications (WPC)
 Permissions for Import of Re-furbished Machines from Ministry of Environment
 Permissions for Import of Batteries for Medical Instruments from Pollution Control Board
 Clinical Trial Permissions from Indian Council of Medical Research (ICMR), New Delhi
 Performance Evaluation Report for Critical Diagnostic Kits viz. HIV, HBsAg, HCV and Blood Glucose Monitoring
Strips from National Institute of Biologicals (NIB)
 R&D Approval from Department of Science and Industrial Research (DSIR).
Nutraceuticals:
 New Product Registration and Central License from Food Safety Standard Authority of India (FSSAI)
 Registration, State License and Manufacturing License etc. from State Food Safety Standard Authority.
Concern Departments:
 CDSCO, New Delhi
 Zonal and Local Drug Authority (FDA)
 Wireless Planning & Coordination Wing,
Department of Telecommunications (WPC)
 National Institute of Biologicals (NIB)
 Ministry of Environment
 Pollution Control Board
 Indian Council of Medical Research (ICMR)
 Department of Science and Industrial Research (DSIR).
 Food Safety Standard Authority of India (FSSAI)
KEY RESPONSIBILITIES AS QA AND QC HEAD
 Quality Head & responsible for managing the operations of Process, Projects, Materials, Engineering, Packing &
Administratively QA/QC etc.
 Maintain the facilities in conformance to cGMP’s and other regulatory requirements of the markets and to keep
them in validated state
 Accountable for auditing, upgrading and harmonizing Systems, SOP's, Documents, including validations, to meet
the required cGMP, ISO standards
 To efficiently use the resources to meet production targets and be competitive in terms of quality and efficiencies
with the best in the industry
 Implementation of cGLP
 Quality control of raw Materials
 Quality control of finished products
 Ensure all testing performed and Approve
specifications
 Approval or rejection of materials
 Maintain department, premises and records
 Inspection, investigation, and taking samples
 Evaluate batch records Initial and ongoing
training
EDUCATIONAL CREDENTIALS
 Master of Pharmacy (Pharmaceutical Chemistry) 2010
I.T.S. Pharmacy College, Ghaziabad
 Bachelor of Pharmacy 2008
R.R.S. College of Pharmacy, Amethi
CO-CURRICULAR ACCOLADES
 GATE Score 2008, 81.53 percentile (Graduate Aptitude Test for Engineering and Pharmacy)
 Advanced Diploma in Computer Software and Applications
 Participated in Indian pharmaceutical congress in 2007 held at B.H.U., Varanasi as a volunteer
 Participated in Indian pharmaceutical congress in 2009 held at New Delhi
PERSONAL
Father’s Name : Late Hari Krishna
Address : 167/1A, Mandir Lane, Sarai Jullena, New Friend’s Colony, New Delhi 110025.
Mobile : +91-8882524228, +91-8285599325

3. PRIYANK SRIVASTAVA
Contact: +91- 8882524228, +91-9625364839
E-mail: priyanksrivastva@gmail.com
Email : priyanksrivastva@gmail.com
Passport No : Z2128505 Valid up to 04-01-2022
References : Available on request.
Priyank Srivastava New Delhi