Regulatory Consultancy
Medicinal products and health products are the focus of all the services provided by Diapharm Regulatory Services GmbH: as a management consultancy specifically serving the pharmaceutical industry and specializing in complete solutions, we support the development, marketing authorization and management of pharmaceutical products.
Our broad technical know-how relating to medicinal products, food supplements, cosmetics and medical devices is an excellent basis for analysing and providing strategic advice even on complex product portfolios. As a service provider to the pharmaceutical industry, Diapharm assumes responsibility for managing existing marketing authorizations for medicinal products and health products and for managing all aspects of even extensive product portfolios (read more).
In pharmaceutical business development we produce innovative product and marketing strategies for our customers, manage product developments and initiate marketing authorisation projects, implementing them as closed funds (pooling projects). This provides participating distribution companies with attractive products for their brand portfolio while minimizing the regulatory work involved.
As regards documentation, we handle notifications of change (variations) and the updating of marketing authorization dossiers for our customers (read more). Diapharm Regulatory Services GmbH also produces complete dossiers as eCTDs (electronic common technical documents).
Diapharm can also use its expertise to help you develop new marketing authorisation strategies for health products (read more) such as
- generic marketing authorisations
- OTC products
- phytopharmaceuticals, e.g. traditional herbal medicinal products (THMP)
- medical devices
- food supplements for children, dietetic food
Our specialists keep an eye on the formal, technical and legal aspects of regulatory work at all times.
Our range is supplemented by management consultancy specifically tailored to pharmaceuticals – all the way through to M&A. As a special additional service we also assume responsibility as qualified person for pharmacovigilance, as safety officer or information officer.
Diapharm is therefore the ideal outsourcing partner for pharmaceutical distributors, offering all the business services needed for the distribution of medicinal products and health products.
