Regulatory Affairs

Complete preparation and submission of application files (CTD modules 1 – 5) for national , German and European registration procedures
Submission of Marketing authorisation applications for chemical APIs as well as for traditional herbal medicinal products (THMP)
Submission of applications for well-established-use medicines
Support for extension of marketing authorisations (line extensions), preparation and submission of applications for line extension
Conduction of European MR- and DC-procedures, transiently acting as holder of marketing authorisation
Investigation of submission strategies
Regulatory support with strategic questions and product development issues
Evaluation and preparation of advisory requests at regulatory authorities (Regulatory Advice, Scientific Advice)
Compilation of briefing documents for consultations with health agencies
Submission of applications and accompanying of registration processes on national and international level, procedure management, health authority contact

Preparation of marketing authorisation dossiers for registration of medicinal products for human use in Germany and within the European Union (modules 2 to 5 of the CTD)
Preparation / Revision of module 3 (quality, CMC)
Preparation of the chemical-pharmaceutical expert report (Quality Overall Summary, module 2.3 of the CTD)
Preparation of documents / up-date of documents of single parts of the CTD Dossier for submission to health authorities
Changes to the format of dossiers from NTA-format into the CTD-format
Compilation of environmental risk assessments (ERA)

Preparation of documents and submission of renewals of licences on national and international level
Preparation of documents and submission of variations of licences on national and international level
Compilation of answers to deficiency letters of the health agencies and for conditional marketing authorisations
Continuous life cycle maintenance of regulatory files, including up-dates (full maintenance services)
Change control procedures and change control management
Complete out-sourcing of your documentation to us and provision of life cycle maintenance

Conduction of readability user testing of patient information leaflets in support of applications for marketing authorisation

Acceptance of responsibility as Representative for Information according to German Drug Law
Support with translations of product information texts and other medicinal texts, review of provided translations and implementation of necessary corrections
Provision of support directly in our clients’ own offices