We make complex things easier – all the way from idea to market – with focus on Life Science industry and complete solutions in all aspects of regulatory compliance. Development of medical devices and pharmaceuticals is a complex, demanding task and never a straight forward mission, especially when it comes to handle regulatory requirements. Further down the road of development, the products are eventually ready to be put on the market – which is yet another challenge.
Key2Compliance® is a full-service partner that you can Rely on during your journey. You can get support in all aspects of consultancy and training when it comes to Clinical Development, Biological Evaluations and Toxicology, Quality Assurance and Regulatory Affairs.
Current business areas
- Quality Assurance: Quality system, GXP, technical files, inspections, audits, PRRC responsibility and more
- Regulatory Affairs: Technical files and other Documentation and CE markings, FDA approvals and registrations, access to other markets, UK responsible person
- Biological Evaluations and Toxicology: Biological evaluation, material documentation, recommendations, reports and more
- Clinical Development: Clinical evaluations, prospective clinical studies, performance evaluations for IVD and post marketing studies.
- Training and Courses: World-leading training for Pharmaceutical and Medical Device companies
Key2Compliance® will be your partner – Rely on us