Regulatory Affairs

Genex Pharma owns proficiency and expertise in meeting all the desired regulatory approvals & requisites in conducting International business. We possess a dedicated regulatory team consisting of technical professionals having vast experience, great capability and in-depth knowledge in their field.

Rigorous implementation of scientific documentation in the process controls and pervasive capabilities coupled with technical know-how of our team, has catapulted in having speed and efficiency in business processes.

We have up-to-date regulatory documentation, as stated below, required to prepare technical dossier:

  • Manufacturing License
  • WHO-GMP certificate
  • Certificate of Pharmaceutical product / Free Sale Certificate
  • Registration dossiers with real time Stability Studies

Readily available dossiers, both CTD as well as ACTD for our complete range of products give us a competitive edge, enabling us to register majority of our products in Latin American countries and South East Asia.

The strong networking with the regulatory authorities and in-depth knowledge of a regulatory team reduces turn - around - time in initiating business and achieving faster business momentum.