Regulatory Affairs Services

General services

We work with all related authorities such as ministries of health , municipalities and others.

  • Regulatory Affairs consultation
  • Regulatory affairs strategy development
  • Act as an Agent or Authorized Representative
  • Marketing Advertisement approval
  • Out sourcing RA candidate or the full RA department
  • Innovative regulatory roadmaps
  • Good manufacturing practice (GMP)
  • Marketing Advertising approvals
  • Product trademark protection and registration
  • Importation process approvals
  • Regulatory affairs candidate Resource

Product and related services

We cover all the activities related to pharmaceuticals, medical devices, herbal, supplements, cosmetics and all FMGC products such as:

  • Company & Manufacturer Registration / Renewal
  • Product classification
  • Product registration / Renewal
  • Labeling validation and modification
  • Medical translation (e.g. labels and leaflets)
  • Product lifecycle management (variations and renewal)
  • Dossier preparation (CTD & e-CTD)
  • Laboratory Test and analysis
  • Pharmacovigilance: implementing a system relating to authorities’ guidelines