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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