Regulatory affairs

  • We have extensive experience of producing submissions to all major African Authorities.

  • We cover North West Africa and French West Africa and beyond.

  • We assist at all stages of the product lifecycle, in all types of regulatory submissions starting from early phase development to the post-authorization maintenance phase.

  • Regulatory strategy plan. Regulatory intelligence and outsourcing

  • Compilation, Liaising with Health Authorities.

  • Applications, follow up until approval, Post-authorization and Maintenance support

  • Labeling Material development.

  • We holds Marketing Authorizations in French West Africa