What We Do
DifGen is a generics company with a primary focus on developing difficult and differentiated generics affordable to everyone. We have developed strong expertise over the years in the areas of formulation, analytical development, Drug Quality Assurance (DQA) and regulatory capabilities.
ANALYTICAL R&D
1. Qualification of APIs
2. Reverse Engineering
3. Complex Analytical Characterization
4. Computer LAI
5. Charectrization of Lipozomes
DRUG QUALITY ASSURANCE (DQA)
1. Quality Management System
2. Qualified Software
3. Documents review and authorization
4. Periodic training
5. Efficient Document archival and retrieval
PREGULATORY SUPPORT
1. Dossier preparation
2. database creation
3. Clinical CROs Report revies
4.Line Extension
5.Efficient and strategic query response
6. Product Life cycle management