Regulatory services
Regulatory services cover all areas related to the regulation and management of pharmaceuticals and medical devices. We work with both pharmaceutical clients and regulatory authorities to ensure that all processes related to the regulation of therapeutic substances are conducted in compliance with local or regional laws. Our team of experts is available for both long-term and short-term projects, providing our clients with the highest-quality services on the market.
We offer our clients a comprehensive range of services in the following areas of regulatory affairs:
- IVDR (In-vitro Diagnostic Medical Devices Regulation)
- Regulatory strategy
- Pharmacovigilance
- Regulatory compliance
- Medical Device Regulation (MDR)
- Clinical Trial Regulation (CTR)
- Clinical trial operations
- Market authorization of medicines
