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

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