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