Medicinal product service from regulatory affairs to GMP audit

We support companies in developing, testing, manufacturing and marketing medicinal products – and making them a business success.

Ideas, concepts and licenses for medicinal products

Ideas and concepts for medicinal products

We develop innovative ideas and products that provide added value, along with legally viable strategies – for both OTC and prescription-only medicinal products. You can even find a selection of available OTC products on our website.

Medical and regulatory affairs, pharmacovigilance

We help our clients meet requirements efficiently. Our teams of specialists for medical and regulatory affairs take care of preparing CTD dossiers, summaries of product characteristics (SmPC) and other documents. They also manage marketing authorisation procedures and maintain existing marketing authorisations. And the Diapharm pharmacovigilance team monitors the safety of many medicinal products on a constant basis.

Analytics and quality management

Diapharm supports pharmaceutical companies throughout all manufacturing and marketing phases. We evaluate and audit the quality management of manufacturers and marketing companies and conduct GMP audits ofmanufacturers of active pharmaceutical ingredients (API). Our pharmaceutical laboratory tests the quality of medicinal products before, during and after marketing authorisation.

Assuming responsibility

We lighten our clients’ load by assuming the responsibility associated with positions required by law, such as qualified person for pharmacovigilance (QPPV, 24/7), information officer, qualified person (QP) or marketing authorisation holder (MAH).