Regulatory Affairs Services

Clinquest’s Regulatory Affairs Team supports biotechnology, pharmaceutical, medical device, and medical diagnostics companies on project management, regulatory strategy and operations, technical writing, and SOP development.

Regulatory Affairs Core Services:

  • Develop international regulatory strategic plans for each stage of development
  • Develop, write, compile, and review regulatory submissions, including IND, NDA, BLA, PMA, ANDA, CTA, IMPD, annual updates, risk management and evaluation plans, and other supplements 
  • Review of CMC, preclinical pharmacology and toxicology documents
  • Provide regulatory support for clinical trials
  • Provide full regulatory support for key Milestone meetings with Regulatory Agencies 
  • Train and advise personnel on regulatory requirements and topics
  • Manage regulatory inspections
  • Support post-marketing services including annual reports, field alerts, promotional material review, and manage risk management or evaluation programs.
  • Prepare and coordinate eCTD submissions