Pharmaceutical Regulatory Affairs Services

Regulatory Affairs consultancy services for the medical and pharmaceutical industries.

Intertek's regulatory affairs consultants assist companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements. Our qualified experts can provide consulting advice from the early pre-IND/pre-CTA/pre-IDE stage of pharmaceutical development through to marketing applications.

Pharmaceutical Regulatory Affairs Services:

• Dossier/submission preparation or review and filing
  • Pre-meeting packages, INDs/CTAs/IDEs and post-filing submissions, BLA/NDA/NDS/MAA/510(k)/PMA filings (US, Canada, EU)
  • Submission preparation to other worldwide agencies in European countries, South America, Australia, and Asia
   
• Development of regulatory strategy for the product’s life cycle
  • Consideration of international regulatory requirements
  • Meeting international filings
  • Revision of plans as guidelines change
   
• Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process
  • Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
  • Respond to regulatory agency questions
   
• Regulatory classification of products across different jurisdictions
• Provide expert regulatory CMC compliance advice throughout development
• Work with Sponsors and regulatory authorities through the resolution of complex development issues
• Act as US Representative for US submissions, as EU Agent in Europe, and as Canadian Representative for Canadian submissions
• Assist with due diligence activities for investors/licensees
• Scientific and medical writing services