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)