Regulatory Affairs

Our services for regulatory affairs

The ever-increasing requirements for pharmaceuticals must be implemented in an efficient regulatory affairs strategy. In order to prove the efficacy and tolerability of your drug, a scientifically sound and regulatory safe approach, careful documentation for regulatory submissions, and professional management of clinical trials are required.

This applies to new submissions through national approval procedures, MRP procedures (Mutual Recognition Procedure), DCP procedures (Decentralised Procedure), and CP procedures (Centralised Procedure). It also relevant to revisions of dossiers for new procedures or complex change notifications, variations including indication extension, change of contract manufacturer, change of primary packaging, new manufacturing method, a new name, claim changes, the change of a drug from Rx to OTC status, and marketing authorisation extensions (Renewal).

Our project management accompanies you through individual variations. However, we also support the entire process, from the development of the strategy and its implementation to the submission and granting of marketing authorization. We also help you through our network to find another contract manufacturer, primary packaging material, other active ingredient manufacturers etc.

We are happy to support you! Just contact us.