Regulatory Strategy
Navigating regulatory pathways is increasingly complex. Diapharm works with clients to define project objectives and identify the optimal regulatory route. This includes not just the type of submission but also required documentation, timelines, and associated costs.
Diapharm works closely with its clients to define project goals and map out the optimal regulatory pathway to achieve them. The regulatory strategy goes beyond selecting the type of submission — it also takes into account the required documentation, timelines, and associated costs. For particularly complex or contentious issues, it is advisable to consult the competent authority (such as BfArM or PEI in Germany) to clarify critical points and align regulatory strategy accordingly
Dossiers
The field of Regulatory Affairs encompasses all activities required to obtain and maintain the marketing authorization or registration of a medicinal product. Central to this is the preparation and ongoing management of the medicinal product dossier: Diapharm compiles all relevant data—including preclinical and clinical studies on safety and efficacy, information on the quality and analytical testing of the medicinal product, details on its intended use, pharmacovigilance, and much more—into the electronic Common Technical Document, or eCTD dossier.
Marketing Authorization
To identify the optimal authorization procedure, existing documents and dossiers are assessed to determine strategically and regulatory sound options. Diapharm also provides support for Scientific Advice meetings with the relevant authority.
Diapharm manages and oversees a range of marketing authorization procedures, including:
- National procedures,
- Mutual Recognition Procedure (MRP),
- Decentralised Procedure (DCP),
- Centralised Procedure (CP).
Even after a successful marketing authorization, Diapharm remains a trusted partner for clients throughout the entire lifecycle of a medicinal product (Life Cycle Management). Existing dossiers must be updated to comply with current legal requirements, which may involve submitting variations when necessary. In addition, renewals must be filed on time to maintain long-term authorization.
Diapharm can take on full life cycle management for products or act as the Marketing Authorization Holder (MAH), taking on complete responsibility for the product.”
To place medicinal products on the German market, additional regulatory requirements must be met beyond obtaining marketing authorization — including serialization, compliance with packaging laws, inclusion in the Lauer-Taxe, and applying for a Pharmazentralnummer (PZN). Diapharm manages these pre-launch activities on behalf of its clients.
