The regulatory environment for devices, diagnostics and complementary and alternative medicines (CAMs) is changing. This includes the requirements from regulatory authorities across the world, including the FDA and EMEA. Allow us to support you from your research and development phases, registration and commercialisation and reaching your objectives.
Clinical trials for devices, diagnostic and CAMS
As a result of increasing regulatory pressures globally, the market has evolved to become more sophisticated with more requirements to register new devices or make clinical claims. Allow our scientifically skilled team to assist you in innovative ways to collect robust data in support of your product claims and registrations.
Produce a wide range of documents that comply with relevant standards and regulations to ensure robust scientific research leading to timeous market approval. Weâ€™ll help you create well-written, credible documents for all phases of your product life-cycle from protocol development to marketable value stories.
Generate, integrate, collect and manage high-quality, reliable data from your research trials using our tech-forward approach.
Monitoring of clinical trials is one of the cornerstones of high-quality research. Our experience in monitoring will ensure all projects are completed in a timeous manner, at the highest quality and according to all relevant standards and regulations. All our staff are Good Clinical Practice (GCP) registered according to international requirements.
Project management is a key component of our commitment to you. To facilitate timeous project completion, all projects are mapped out on a web-based project management tool. This allows you to follow progress, view responsibilities, and engage in all project-related communications.
Regulatory and Ethics approval
Governed by stringent regulatory frameworks, our projects are always in-line with current regulations and required approvals. Respect for the dignity, safety and well-being of participants and their data is our primary concern, therefore all projects will receive regulatory and/or ethics approval prior to project initiation. Along with our broad industry knowledge and contacts we can assist you in your product registrations, legal advice and consulting. We have a specialist cross-functional teams with many years of experience in regulatory approval and are able to provide the best advice tailored to your needs.