Regulatory Competence Center

FDF

In June 2015, in line with the new strategy of the Pharma Business Unit, a new regulatory structure was created to manage all the regulatory activities related to the maintenance of in-house or in-licensed dossiers. Some of the responsibilities are:

• Submission of MA dossiers and follow-up with the competent authorities
• Supporting clients regarding all essential activities of the lifecycle of medicinal products, such as variations, renewals, etc.
• Coordination of the packaging materials approval process
• Expertise in regulatory strategy and worldwide regulatory requirements.

In addition the Competence Centre has a specific focus on the MENA Region, with the following key responsibilities:

• Building deep knowledge of the regulatory requirements for MENA region
• Creating a single point of contact for the MENA clients and optimizing communication while improving the efficacy of the processes.

API

• Specific expertise in DMFs: Your partner for CEP approvals.
• We offer a dedicated and well-staffed team that will fully support you in getting your DMF submitted to the Authorities