Regulatory Affairs

Regulatory Affairs

  • Complimentary to the CGMP is Regulatory Affairs.
  • Belican Pharma, not only ensures Preparation & Filing of Dossiers, but also ensures that any CHANGES, which are CRITICAL are aligned with the Regulatory requirements.
  • We follow the US, EU and WHO Geneva requirements for filing of Variations, taking care of in – depth studies required to ensure the Approval of the variation in US and or EU
  • Our EXPERTISE ensures the smooth Approval of any variations filed, without any hiccups, which are the stomachache of any organization.