Generic Product Development
Primera PharmaLab’s experts are experienced in generic drug formulation and ANDA analytical projects. We can help you in:
- Formulation development that provides:
- Bioequivalence to referenced products
- High quality and less trouble in future manufacturing.
- Timeline orientation with full awareness of completion time.
- Document review for your filing
Our regulatory experts will help you review filing documents for:- Soundness of experimental data
- Integrity and format of the documents and reports
- Clinical manufacture in our affiliated cGMP laboratories.
- Dissolution testing (USP Apparatus I and II)