Regulatory Submissions

DPT combines an extensive understanding of the regulatory approval process with an exemplary regulatory history to fully support our clients’ pharmaceutical development programs.

DPT provides regulatory submission support such as in-house preparation of Modules 2 and 3 (CMC) drafts of the Common Technical Document (CTD) as part of clients’ pharmaceutical development projects.

Key Customer Benefits

  • 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 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 customer’s regulatory department

DPT integrates drug development with quality and regulatory to ensure the best minds are working together on the project and strengthen regulatory submission support. Making this a collaborative process means each submission benefits from the full breadth and depth of expertise at DPT.

This collaborative working model for regulatory submission support extends to the client’s regulatory department. DPT works through the regulatory approval process with the client’s team in an open and direct manner to ensure everyone is focused on the same goals.