Regulatory Affairs

Today, Regulatory Affairs is no longer merely understood as accounting management of regulatory submissions. Proactive strong regulatory functions open up opportunities, save money and make that little difference to your competitors. With our diligence and expertise, we support and advise you in preparing and maintaining your registration documents.

Dossier Creation & Life-Cycle Management

The medicinal product dossier is an indispensable element for submitting and maintaining the marketing authorization of a medicinal product. The stringent regulatory requirements demand an enormous commitment of resources and capacity. To help you with this endeavor, we are happy to support you with:

• Complete preparation of a dossier (national, MRP/DCP, CP)
• Regular review & update of your registration dossier
• Preparation of dossiers for end-of-life products
• Preparation, submission & processing of appropriate submissions/ variations/ renewals
• Monitoring and implementation of deadlines (e.g. Sunset Clause)
• Execution of regulatory compliance checks & gap analyses
• Text creation of SmPC & PIL
• Submission of a Paediatric Investigation Plan‍ (PIP)
• Creation of expert reports ‍
• Environmental Risk Assessment
• Preparation of Investigational Medicinal Product Dossier (IMPDs) & dossier compliation
• Upload to EU portals & registers
• Maintenance of regulatory database

Regulatory strategy

Amidst the escalating complexity of regulatory challenges, market authorization holders must prioritize a carefully considered strategy. Possessing a well-defined strategy not only provides a significant edge over competitors but is crucial in navigating the intricate regulatory landscape. Therefore, it is imperative to establish clear goals and outline a comprehensive "regulatory intelligence" strategy that encompasses all relevant aspects. Our services include:

• Strategic planning of a project
• Cooperation with the authorities (scientific advice)
• Coordination of regulatory roll-outs
• Monitoring of the regulatory environment
• Advice on the development of new products

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