Regulatory Affairs

Lefratis Marketing Strategy

The knowledge of the regulatory environment is pivotal to anticipate and manage the levels and stages involved in the pharma regulatory and registration procedure.

As the pharmaceutical industry is highly regulated, our knowledge of local industry requirements and established contacts with Government Regulatory Agencies ensure the professionalism in the administration of the registration procedure and our dedicated department conducts the Regulatory Support Services & documentation, including Quality Management Services.

Our know-how and experience in the regulatory affairs, registration process and requirement of the local market enables facilitating the following:

  1. 1.Requirements for registration of products and plant approvals.
  2. 2.Examination and submission of the registration dossiers.
  3. 3.Managing the registration process.
  4. 4.Obtaining Marketing Authorization.

We ensure the continuous monitoring of all registration activities at all times and help our clients to meet regulatory obligations through guiding and advising on the full range of laws and regulations governing the pharmaceutical sector in each country of French Speaking African Countries.