Shivkumar Prajapati
Ahmedabad,India
Summary
Global Regulatory Affairs leader with 19+ years of experience across ANDA submissions, complex generics, Pre-IND/IND, NDA 505(b)(2), and biosimilars, supported by a strong background in clinical, bioanalytical research and CRO regulatory operations. Demonstrated expertise across US FDA, EMA, and MHRA regulatory frameworks, with strengths in Module 5, Module 4, Clinical/Nonclinical summaries, and CDISC datasets authoring/review, eCTD publishing, FDA submission execution via ESG, and post-approval lifecycle management (PLCM), including drug–device combination products and device-related regulatory submissions such as Notified Body Opinion (NBOp) as per EU MDR Article 117. Recognized for building compliant regulatory systems, leading cross-functional teams, and delivering timely, high-quality global submissions. Provides senior-level leadership in regulatory submission strategy and structured health authority engagements, including Pre-IND, Pre-ANDA, Scientific Advice, and Controlled Correspondence, with a proven ability to manage deficiencies and complex regulatory interactions across regions. Grounded in early-career bioanalytical and CRO experience, offering strong understanding of global inspection readiness, regulatory compliance expectations, and cross-functional coordination, enabling pragmatic, risk-based regulatory decision-making at a global leadership level.
Overview
21
21
years of professional experience
Work History
Assistant General Manager
Kashiv Biosciences, LLC, Ahmedabad
2021.09 - Current
- Lead global regulatory strategy and execution for biosimilars, ANDA, NDA 505(b)(2), complex generics, CGT designation and NBOp for drug-device combination across the US, EU, and UK from development through approval and commercialization.
- Provide ownership for Module 5, and Module 4, CDISC (SDTM/ADaM) datasets, Clinical and nonclinical Study Reports/summaries, preparation/review and eCTD publishing for regulatory submissions.
- Oversee end-to-end eCTD publishing (Freyr Submit Pro software) and lifecycle management, including submission, amendments, and responses via FDA ESG.
- Author, compile, and critically review eCTD Modules 1–5, ensuring alignment with FDA, EMA, MHRA, CDSCO, and ICH requirements.
- Prepare and review Module 1 regional administrative documentation and submission readiness checklists for Biosimilars, Pre-IND, IND, 505(b)(2), and ANDA.
- Lead health authority interactions including FDA Pre-IND/Pre-ANDA meetings, Controlled Correspondence, and EMA Scientific Advice.
- Manage deficiency response strategies (IRs, CRLs, DRLs) in coordination with cross-functional SMEs.
- Drive post-approval lifecycle submissions (CBE-0/30, PAS, Annual Reports, PADERs, OPDP, Lot distribution etc.).
- Lead EU MDR Article 117 NBOp submissions and support FDA drug–device combination product filings and Support FDA drug–device combination product filings, ensuring alignment between device documentation and drug dossiers. Provide regulatory oversight for design controls, device change management, human factors/usability inputs, IFUs, and labeling alignment across regions
- Manage India regulatory submissions via SUGAM/NSWS, including RCGM approvals, IBSC meetings.
- Review Drug Master Files (DMFs) and applicable device component master files to support global filings.
- Partner with QA, Manufacturing, Supply Chain, and Quality Systems to ensure compliant implementation of changes and sustained inspection readiness
- Coordinate with external vendors and consultants to facilitate timely, compliant submissions.
- Conduct regulatory due diligence for in-licensing, acquisitions, and third-party dossiers, presenting risk-based recommendations to executive leadership.
- Built, trained, and mentored regulatory teams by providing structured guidance on ANDA, IND, BLA, and NDA 505(b)(2) submissions; PLCM activities; eCTD publishing; clinical and nonclinical dossier development; CDISC data expectations; and global inspection readiness, enabling high-quality, compliant, end-to-end regulatory execution.
- Experience of Regulatory Authorities: Lead the USFDA, EMA, MHRA, NBOP submissions. Supported in USFDA inspections and providing compliance to deficiencies received during inspections.
Deputy Manager
Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad
2017.01 - Current
- Preparation of Module 2.7 & Module 5 for ANDA Submissions
- Review and finalization of Clinical, Bioanalytical & CDISC data.
- Preparing eCTD of Bioequivalence section eCTD Software (i.e., PharmaReady).
- Handling FDA Queries Reply pertaining to Bioequivalence section for submitted ANDAs.
- Handling FDA Deficiencies received during USFDA inspection at CRO-Cadila.
- Review, finalization and Submission of Pharmacovigilance related documents such as PADERs.
- Reviewing the entire ANDA as per ANDA Checklist and RTR requirement.
- Review, correct, and finalise the entire submission for eCTD technical specifications, then submit it on FDA’s ESG, manage EU and UK submissions through CESP, and handle gateway and India submissions via CDSCO Sugam/NSWS, ensuring regional compliance.
- Supporting the CRO team to conduct Bioequivalence studies as per FDA requirement.
- Coordinating with key personnel of other departments in the organization for smooth functioning and timely submissions of ANDAs.
- Other ANDA submissions related activities.
- Experience of Regulatory Authorities: As a team member of Regulatory Affairs (ANDA), involved in USFDA inspections and providing compliance to deficiencies received during inspections.
- Provided the responses to the bioequivalence queries received from the FDA for ANDAs which are under review.
Assistant Manager
Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad
2010.05 - 2016.12
- Handling regulatory/sponsor/monitors queries reply.
- Leading and supporting the team of various professionals for preparation, review & submission of various clinical and bioanalytical study reports, CTD/eCTD submissions, (BA/BE studies) for different regulatory agencies.
- Regulatory Approval/Renewal application process, handling CRO qualification questionnaire, handling DCGI application for T-licence, BENOC and BE study Notifications.
- Harmonization of SOPs/ systems between different sites, coordination with sponsors and compliance to their requirements, quality control/ quality assurance practices.
- Accompany Regulatory Inspectors/ Sponsor / Monitors during facility inspection / visit.
- Monthly Evaluation and Reporting of total output of department to Head/Management.
- Yearly Evaluation and Statistical Presentation of Regulatory Queries and Deviations records of Organization.
- Vendor inspections, finalization and accountability of vendor records.
- Training to concerned staff members.
- SOP preparation, review and revision.
- Accountability of deviation records.
- Accountability of change control records.
- Coordinating with key personnel of other department in the organization including the head office for smooth functioning and timely accomplishment of department assignments.
- Review and evaluation of specific activities like change control process, investigation of event/incident, evaluation of deviations reported in the organization.
- Coordinating with sponsors & regulatory inspectors during site inspections, system harmonization between different sites, etc.
- Experience of Regulatory Authorities: As a team member of regulatory affairs department involved and played vital role during various regulatory inspections like USFDA, DCGI, WHO, ANVISA, EMEA (ANSM-France, DHMA-Denmark and MPA Sweden), MoH-Turkey, etc.
- Involved in providing compliance to numerous deficiencies/ inspection reports received from different regulatory agencies.
Sr. Research Associate
Lambda Therapeutic Research Pvt. Ltd., Ahmedabad
2008.09 - 2010.04
- Working as an Analyst in a team and as well as individually under supervision of group leader/ Lab manager to perform following activities:
- Development and validation of selective and sensitive Bioanalytical methods (LC-MS/MS) for the quantitative determination of drug and their metabolites in biological matrix by using various applicable techniques.
- Bioavailability / Bioequivalence study sample processing and analysis.
- Proper documentation & Verification of Validation, Study raw data (Chromatograms, Forms, Journals, relevant Log Books etc.) & other relevant Bio-analytical document as per relevant SOPs, SOTPs and Protocol.
- Compliance to QC/QA observations.
- Maintenance and calibration/ performance check of assign/designed instrument and maintaining the records.
- Maintaining & daily monitoring of all facility area of the laboratory for GLP compliance.
- Training to concerned staff members.
- Other administrative / System related activities as assigned by the Bioanalytical Investigator.
- Experience of Regulatory Authorities: As a team member of bioanalytical laboratory, I was once involved in preparation for ANVISA inspection.
Technical assistant
Torrent Research Centre, Bhat, Gandhinagar
2005.11 - 2008.09
- Working as an Analyst in a team under supervision of group leader/ Lab manager to perform following activities:
- Development and validation of selective and sensitive Bioanalytical methods (LC-MS/MS) for the quantitative determination of drug and their metabolites in biological matrix by using various applicable techniques.
- Bioavailability / Bioequivalence study sample processing and analysis.
- Proper documentation & Verification of Validation, Study raw data (Chromatograms, Forms, Journals, relevant Log Books etc.) & other relevant Bio-analytical document as per relevant SOPs, SOTPs and Protocol.
- Compliance to QC/QA observations.
- Maintenance and calibration/ performance check of assign/designed instrument and maintaining the records.
- Maintaining & daily monitoring of all facility area of the laboratory for GLP compliance.
- Training to concerned staff members.
- Other administrative / System related activities as assigned by the Bioanalytical Investigator.
- Experience of Regulatory Authorities: As a team member of bioanalytical laboratory involved in preparation of first time USFDA inspection of bioanalytical laboratory. Also once involved in ANVISA inspection for approval of bioanalytical laboratory.
Education
M Sc. TQM - Clinical Research
Kuvempu University
2011-02
B. Pharm - undefined
Saurashtra University
2005-04
Timeline
Assistant General Manager
Kashiv Biosciences, LLC, Ahmedabad
2021.09 - Current
Deputy Manager
Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad
2017.01 - Current
Assistant Manager
Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad
2010.05 - 2016.12
Sr. Research Associate
Lambda Therapeutic Research Pvt. Ltd., Ahmedabad
2008.09 - 2010.04
Technical assistant
Torrent Research Centre, Bhat, Gandhinagar
2005.11 - 2008.09
B. Pharm - undefined
Saurashtra University
M Sc. TQM - Clinical Research
Kuvempu University
INSTRUMENT HANDLED
LC-MS/MS; TSQ Quantum Ultra & HPLC-SHIMADZU LC-20 with software LC Quan, Liquid Handling System (LHS) and other relevant instruments equipped in bioanalytical laboratory.
PRESENTATIONS AND INVITED LECTURES
- Delivered a lecture on “Schedule-Y” which was a part of ‘Advanced GCP’ Training conducted at Ethicare Clinical Trial on Services on 2015-05-16 as a part of external training program.
- Given Presentation on below topics as a part of Annual General Training Program at Accutest:
- On “Evaluation of regulatory Queries and Deviation Records” in Year 2015.
- On “Accutest @ ANVISA” in Year 2015.
- On “Evaluation of regulatory Queries and Deviation Records” in Year 2014.
- On “USFDA ‘Refuse to Receive (RTR)’” in 2014.
- On “Current requirements of BA/BE studies by different regulatory agencies” in Year 2014.
- On “Evaluation of regulatory Queries and Deviation Records” in Year 2013.
- On “Quality Management Systems” in Year 2012.
- On “Why eCTD” in Year 2011.
SELF DECLARATION
I do here by declare that the information given in this record is true to do the best of my knowledge and belief.
CORE REGULATORY EXPERTISE
- Global Regulatory Submissions & Strategy
- ANDA | NDA 505(b)(2) | Pre-IND / IND | Biosimilars | BLA support | MAA (EU DCP/MRP/NP) | UK National Procedure | CTA | CGT | Complex Generics |
- Clinical & Nonclinical Dossier Expertise
- End-to-end ownership of Module 4 and Module 5, including clinical and nonclinical study reports, summaries, bioanalytical data, and CDISC datasets (SDTM/ADaM); preparation, critical review, and regulatory alignment of dossiers across regions
- Module 1 & Administrative Documentation
- Regional Module 1 content, FDA application forms, Letters of Authorization, DMF cross-references, and RTR-ready submission checklists for Pre-IND, IND, ANDA, NDA 505(b)(2), and biosimilar submissions
- Publishing, Gateways & Lifecycle Management
- ECTD publishing and lifecycle management for original submissions, amendments, and responses using Freyr and PharmaReady eCTD software, Lorenz eValidator, and submission via FDA ESG and CESP (EU/UK), and CDSCO Sugam / NSWS.
- Health Authority Interactions
- FDA Pre-IND and Pre-ANDA meetings, Controlled Correspondence, EMA Scientific Advice, MHRA interactions, and coordination of regulatory responses aligned with agency expectations
- Deficiency & Regulatory Issue Management
- Strategic management of Information Requests (IRs), Complete Response Letters (CRLs), Deficiency Response Letters (DRLs), and inspection-related observations through cross-functional SME coordination
- Post-Approval Lifecycle Management (PLCM)
- CBE-0, CBE-30, PAS, Annual Reports, PADERs, OPDP submissions, and lot distribution reports, including global change impact assessment and implementation
- Drug–Device Combination Products
- EU MDR Article 117 Notified Body Opinion (NBOp) submissions; FDA drug–device combination product support, including device technical documentation, design controls, human factors/usability inputs, IFUs, and labeling alignment
- India Regulatory & Biologics Governance
- CDSCO submissions via Sugam / NSWS, RCGM filings, IBSC meetings, and statutory compliance for clinical and biologics-related activities
- Leadership, Governance & Due Diligence
- Regulatory team building and mentoring, SOP development, global inspection readiness (FDA, EMA, MHRA, CDSCO), vendor and consultant oversight, and regulatory due diligence for in-licensing and third-party dossiers.
CONFERENCES ATTENDED
Attended the fifth Applied Pharmaceutical Analysis (APA) India meeting held between 23rd to 26th Feb 2014 at Hyatt Ahmedabad.
PROFESSIONAL TRAINING
- Workshop on CDISC & eCTD conducted by Aurelius, Mumbai at Ahmedabad from 2017-04-24 to 2017-06-17
- Workshop on CDISC - CDASH, SDTM, ADaM conducted by Cytel Statistical software & Services Pvt. Ltd., Pune at Ahmedabad on 2017-05-31
- Essential of GCP conducted by Accutest Research Laboratories (I) Pvt. Ltd., Ahmedabad at Ahmedabad on 2014-07-09
- GLP conducted by Dr. V.P Shedbalkar, Director (pharma edge centre Pvt. Ltd.) at Ahmedabad on 2013-05-09
- ICH-GCP and Schedule Y conducted by Shivarth Center Of Excellence In Clinical Research at Ahmedabad on 2013-05-02
- Workshop on evaluation of basic pharmacokinetic parameter & confidence intervals from data obtained during bioequivalence study using excel worksheet conducted by Dr. V.P Shedbalkar, Director (pharma edge centre Pvt. Ltd.) at Ahmedabad on 2010-10-09 to 2010-10-10
- GLP conducted by Dr. Prakash V. Diwan, Project Director at Ahmedabad on 2010-11-18