Regulatory Affairs

• Preparation of marketing authorisation dossiers in CTD format. Pharmacological/toxicological expert reports (Module 2.4, 2.6 und 4), clinical expert reports (Module 2.5, 2.7 und 5) and quality dossier (Module 2.3 und 3)

• Advice, planning and support for application for marketing authorisations in the EU. Development of marketing authorisation strategies and help for choosing the adequate application type

• Updating and maintenance of dossiers

• Writing product information (SPCs), package leaflets and brochures

• Preparation of Investigational Medicinal Product Dossiers (IMPDs) und Investigator Brochures (IBs)

EXPERT REPORTS (CTD) for the marketing authorisation of medicinal products

We take over the preparation of the pharmacological/toxicological expert reports (Module 2.4, 2.6 und 4), clinical expert reports (Module 2.5, 2.7 und 5) and quality dossier (Module 2.3 und 3) in CTD format. We take both your own preclinical and clinical studies as well as the results from a detailed literature search into account. We offer you a complete electronic CTD (eCTD) service for new drug applications.

ADVICE, planning and support for MARKETING AUTHORIZATION PROCEDURE – national and in the EU

We offer you a complete service for application for marketing authorisations, which comprises consultation, compilation, submission and maintenance. We support you in the development of marketing authorisation strategies and selection of the most appropriate application type.

We advise and provide comprehensive support for the following marketing authorisation procedures:

• national procedures at all EU drug regulatory agencies

• centralised procedure (CP) at the EMA

• decentralised procedure (DCP) in all EU member states

• mutual recognition procedure (MRP) in all EU member states

• marketing authorisation of medicinal products with a „well-established medicinal use“ (WEU) in accordance with article 10a of Directive 2001/83 EC

• registration of “traditional herbal medicinal products“ (THMP) in accordance with article 16d(1) of Directive 2001/83/EC

ASSISTANCE with DEFICIENCY LETTERS

We answer queries and deficiency letters from authorities or notified bodies, irrespective of whether we were originally involved as appraisers.

ADDITIONAL SERVICES:

• Updating and maintenance of the dossiers

• Compilation of scientific expert opinions for questions related to non-clinic and clinic topics

• Writing product information (SPCs), package leaflets and brochures

• Preparation of Investigational Medicinal Product Dossiers (IMPD) and Investigator Brochure (IB)