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 At Atome Pharma, our mission is to streamline our partners’ market access journey—from initial application analysis to submission and registration notifications.  

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 Our commitment is 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 We handle the intricacies of compliance, allowing our partners to focus on their core business.

Our specialized pharmacists play an important role in managing connections with various Ministers of Health.

The pharmacist head of RA department is:

  • Responsible for managing the pharmacovigilance activities on behalf of our partners.
  • Training and evaluating our sales team to ensure they are well-prepared and aligned with our mission.
  • Ensuring that Atome Pharma Group is aligned with all pharmacovigilance requirements.  

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