Regulatory Submissions

Our Experts, Your Approval

Our exemplary regulatory record reflects our extensive understanding of the regulatory approval process. We’ll support your project with services such as in-house preparation of Modules 2 and 3 (CMC) drafts of the common technical document (CTD) as part of your pharmaceutical development needs.

To strengthen our regulatory submission support, we involve experts who know how to prepare and evaluate all aspects of submissions for success. Working alongside your team, we ensure everyone is focused on the same goals.

Regulatory Solutions

  • CMC preparatory services for IND, NDA, ANDA, NDS, NADA, ANADA and MAA
  • Defined process for preparation and review of CMC
  • Early involvement in the submission process with cross-functional teams (R&D, quality and regulatory)
  • Experience with, and regulatory knowledge of, semi-solid, liquid, aerosol and inhaled drug products
  • Preparation by persons directly involved in the development and manufacturing processes and who are familiar with DPT systems
  • Coordinated commitments to regulatory agencies with SOPs, processes and specifications
  • Documents prepared in a timely and efficient manner
  • Question-based review (QbR) for ANDAs
  • Q8 Pharmaceutical Development Report
  • Open and direct communication with your regulatory department