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Regulatory Submission Support

Released By DPT

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

Our customers benefit from in-house preparation of Modules 2 and 3 (CMC) drafts of the Common Technical Document (CTD) as part of their 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

Request more information from DPT

Request more information from DPT

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