Regulatory Affairs

Well Pharma is committed to supporting its partners in implementing their regulatory strategy in compliance with local regulations. Its activities include

Our Regulatory Activities

RA Operations

  • Rigorous management of regulatory files, including the registration of pharmaceutical products and the approval of medical devices, with drafting and follow-up until decisions are obtained.
  • Constant monitoring of legislative and regulatory developments.
  • Close collaboration with competent authorities (ANPP, MIPP, Ministry of Commerce, etc.).
  • Translation and validation of artworks, packaging, and leaflets.

Market Access

  • Pricing set in collaboration with relevant parties.
  • Price and reimbursement requests for branded and generic medications.
  • Conducting specific studies to meet client needs.

Pharmacovigilance and Material Vigilance

  • Evaluation and management of pharmacovigilance and material vigilance incidents.
  • Monitoring of marketed products.
  • Liaison with authorities and regulatory assistance in managing product recalls.

Compliance

  • Ensuring adherence to internal rules and regulations governing interactions with authorities.

Need to Reach Us?

For any questions or specific needs, please feel free to contact us.

Address

Lot 399 Tahar Bouchet, Tixeraïne, Birkhadem 16330

Phone

+213 561 95 96 57

Email

m.benachour@wellpharmagroup.com