ServicesRegulatory Affairs

We help our clients achieve positive pharmaceutical regulatory outcomes by using a modern, scientific approach as the driver of success. Using our deep exprerience, we support our clients from pre- through post approval of their registration procedures and compliance with various Health Authorities worldwide.

What we are passionate aboutManaging medicinal product marketing authorisations, preparing and maintaining the documents to go along with them is our speciality.

Pharmaceutical Products
  • Pre-Submission Activities
  • Dossier Submission
  • Post Approval and MA Life Cycle Management
Medical Devices
  • Complete solutions in preparation, update & gap analysis
  • Full Support & Notification of Medical Devices with the Local Health Authorities
  • Direct communication with the Local Health Authorities for the evaluation of the technical file and CE Marking
Cosmetic Products
  • Development of new cosmetic products
  • Identification of CMO for your cosmetic product
  • Efficacy and Safety Assessment
  • Compilation of Cosmetic product safety report
  • Notification on the CPNP portal
Food Supplements
  • Formulation development advice on ingredients list and reformulation
  • Validation mandatory label information & Health and Nutritional Claims
  • Notification process with Local Health Authorities
  • Direct communication with the Local Health Authorities
  • Support with import and export documentation and procedures
Biocidal Products
  • File preparation for Biocidal Products
  • Registration of Biocidal Product files
  • Biocidal product dossier preparation
  • Direct communication and problem solving with the Local Competent Health Authorities
  • Generation of Efficacy tests

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