Regulatory affairs

We offer following services in the field of Regulatory Affairs:

Compilation and evaluation of the Quality documentation (Module 3)

Responses on the deficiency letters from competent authorities

Maintenance of marketing authorisation dossiers after approval: implementation of national  and EU variations as well as renewal procedures

Preparation of the Scientific Advice applications

Consultation on the development of Paediatric Inverstigation Plans

Compilation of the complete Module  1 including Risk Management Plan and Environmental Risk Assessment

Assistance in carrying out of Consultation with Target Patient Groups (Readability User Testing)

Assistance in the preparation of clinical overviews

Development of Investigator Brochures and Safety Management Plans for clinical trials

Creation and maintenance of product information texts

Creation and evaluation of advertising according to the German law on the advertising of medicinal products