Regulatory Affairs Services

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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

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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

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