Our CMC Regulatory Affairs consultants have extensive experience interacting with both FDA and EMEA.

CMC Regulatory Affairs consultants review existing product information and develop proactive strategies for data acquisition and FDA communication. We design questions that elicit actionable responses from reviewers and identify the data necessary for a successful review.

  • Interpret ICH and FDA/EMEA specific guidances
  • Advise the best filing strategy for your product
    • Risk Management Planning
    • CTD Modules 2&3
    • DMF
    • 505(b)(2)

CMC Development Plans — GANTT charts identify critical path activities and timelines for CTD submissions