Crown_cro_ikonit_Regulatory Affairs-white

Regulatory Affairs

The Regulatory Affairs function at Crown CRO has competence in global regulatory affairs activities related to clinical trial applications and marketing authorization procedures for both pharmaceuticals and medical devices.

We provide consultation and tailored training on legislations, regulations and local requirements, as well as planning and preparation of regulatory strategies. We review regulatory documentation, suggest ideas for further development and provide support by offering strategic input when required. Careful consideration is given to project planning and preparation to meet legislative requirements, while applying a global strategic approach that incorporates a view of the market environment.

Our services include advising on, compiling, reviewing and submitting dossiers and applications to Competent Authorities and Ethics Committees. The application process can be a full-service project, or we can provide support in any individual part of it. Our people have a strong track record in working with multinational product development teams, and we can also outsource our employees to give on-site support at the customer’s location.

Regulatory Affairs Services

  • Tailored Regulatory Affairs training
  • Consultation on legislation and country specific requirements
  • Support with regulatory strategies and intelligence
  • Liaison with National Competent Authorities and Notified Bodies
  • Documentation for Clinical Trial Authorization applications and procedures
  • Marketing authorization documentation and procedures
  • CE mark documentation and procedures
  • Product life-cycle management support
  • Regulatory gap analysis and compliance of regulatory documents
  • Consultation for pharmaceutical and chemical documentation