Regulatory Affairs

Launching a new product (pharmaceutical drugs, medical device, OTC etc…) in Africa requires complying with each country’s regulation for registration, renewal, and variation submission. Atome Pharma Group scope is to simplify our Partners’ (market) access from application analysis, to submission and registration notification.  

Atome Pharma Group offers a registration procedure management service for both patent and generic healthcare products ranging from pre-marketing assessment, marketing authorization application to the post-marketing follow-up and the marketing authorization renewal process to ensure product conformity in terms of quality, effectiveness, and safety to the applicable standards. Our Regulatory Affairs service is a solution for a simplified path for drug approval.

Atome Pharma Group has a dedicated team of pharmacists managing the relationship with the different Ministers of Health.

The pharmacist head of RA department is:

  • Responsible for managing the pharmacovigilance activities on behalf of our partners.
  • Trains and evaluates the sales team.
  • Responsible for making sure that Atome Pharma Group is aligned with all pharmacovigilance requirements.  

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