In today’s fast changing environment of the pharmaceutical industry, the due diligence process is of equally high financial importance for seller (our-licensing) and buyer (in-licensing).
Deren Pharma’s team of experienced specialists review individual product data, registration dossiers or entire portfolios to identify and address technical data gaps, ensure compliance with current legislative standards, and identify areas of concern. Our experience can assist in evaluation of a potential opportunity through our services, namely
Due Diligence of Technical Dossier
- Dossier evaluation for Health Agency’s acceptability.
- Technical Specification evaluation as per local pharmacopoeia.
- Third Party or Contract manufactured data evaluation.
- Gap analysis and proposed solutions.
- Labeling Advise.
- Regulatory support for in-licensing and out-licensing of products.
- Dossiers up-dation in preparation for out licensing activities.
- Assessment of regulatory dossier and evaluation of current and planned regulatory strategies
- Evaluation of CMC information to determine current status of manufacturing feasibility and future development needs
We also provide services into,
- Identification of potential buyers.
- Business modeling.
- Negotiations and draft agreements.