Regulatory Affairs
Marketing Authorisation Applications
- 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
CTD-Documentation
- 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)
Post-Authorisation Activities
- 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
User / Readability Tests
- Conduction of readability user testing of patient information leaflets in support of applications for marketing authorisation
Others
- 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