Entity Licensing

Manufacturers of Medicinal Products for Human Use 

  • Instruction of the process to obtain the Manufacturing Authorisation of Medicinal Products for Human Use;

  • Preparation and/or review of Site Master File;

  • Compliance with the GMP Guidelines – Elaboration and/or review of SOP’s;

  • Management of variations and updates.

 

Manufacturers of Medical Devices

  • Instruction of the notification process to perform the Manufacturing Activity of Medical Devices;

  • Management of variations and updates.

 

Wholesale Distributors of Medicinal Products for Human Use

  • Instruction of the process to obtain the Wholesale Distribution Authorisation of Medicinal Products for Human Use;

  • Elaboration and/or review of Good Distribution Practices Procedures;

  • Management of variations and updates.

 

Wholesale Distributors of Medicinal Products for Veterinary Use

  • Instruction of the process to obtain the Wholesale Distribution Authorisation of Medicinal Products for Veterinary Use;

  • Elaboration and/or review of Good Distribution Practices Procedures;

  • Management of variations and updates.

 

Wholesale Distributors of Medical Devices 

  • Instruction of the notification process to perform the Wholesale Distribution Activity of Medical Devices;

  • Elaboration and/or review of Good Distribution Practices Procedures;

  • Management of variations and updates.

 

Retail Establishments of Medicinal Products for Veterinary Use

  • Instruction of the process to obtain the Retail Activity Authorisation of Medicinal Products for Veterinary Use;

  • Elaboration and/or review of the Good Practices Manual of a Retail Establishment of Medicinal Products for Veterinary Use;

  • Management of variations and updates.

 

About