Regulatory Affairs

Our qualified and experienced regulatory affairs personnel can provide you with timely advice covering activities from the early pre-IND/pre-CTA/pre-IDE stage of development through to marketing applications. Through the combined expertise of both our scientific and regulatory staff, we assist companies to plan and manage their product development programs and regulatory needs.

• 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, CMC, clinical and toxicology matters;
  • Responses to regulatory agency questions.
• 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.
• Assist with due diligence activities for investors/licensees.