Regulatory & Pharmacovigilance
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Regulatory & Pharmacovigilance

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Regulatory & Pharmacovigilance

MIC helps in conceptualizing clinical study designs, planning, and exploring innovative approaches/ PK/PD models for proof-of-concept studies of New Chemical Entities (NCE) and New Biological Entities (NBEs).

 

MIC Medical experts support Sponsor in presenting the protocol and study background to the Indian regulatory authority DCGI/Subject Expert Committee (SEC) and US FDA and participate in the Pre-IND meeting, End of Phase 2 meeting (EOP2), and various research funding agencies (DBT/BIRAC) at different stages of drug development.

 

Regulatory and pharmacovigilance services include generation of ICH-GCP compliant protocol, CSRs, PSURs, safety summaries, PV plans, PSURs and CTD documents.

 

Regulatory & Pharmacovigilance

  • Medical expertise in DCGI/Subject Expert Committee (SEC) meeting
  • Pre-IND/IND meeting and End of Phase 2 meeting (EOP2) with the US FDA
  • Patient Safety summaries/Narratives
  • Safety Update Reports (PSUR)
  • Risk Management Plan (RMP)
  • Product Summary File (PSF)
  • Clinical/Non-Clinical Sections of the Common Technical Document (CTD) including Summaries and Overviews
  • Summary Product Characteristics (SPC)
  • Annual Safety Reports (ASRs)