Regulatory affairs
Navigating the regulatory landscape is crucial for the success of preclinical and clinical research. Our regulatory affairs services ensure compliance with industry standards, streamline approval processes, and facilitate market entry for pharmaceuticals and medical devices.
Investigator’s Brochure (IB)
Preparing comprehensive documentation to provide investigators with essential preclinical and clinical data.
Clinical Trial Authorisation (CTA)
Assisting in the preparation and submission of regulatory applications to obtain approval for clinical trials.
Medical Devices Registration
Supporting the registration and compliance of medical devices in accordance with regulatory requirements.