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