Our regulatory team has experience in applying scientific knowledge to create viable and effective pathways for drugs and medical devices to gain approval from regulatory agencies in Europe.
Clinmark’s consultant assigned to your project will work with you to develop a regulatory strategy at an early stage to identify key challenges that may arise and liaise with regulators.
We provide services for single-national as well as multinational clinical trials across the spectrum of therapeutic areas including Oncology, Rheumatology, Endocrinology / Metabolic Disorders, Cardiology, CNS – Neurology and many others.
Our services include:
- Preparation and submission of European CTAs
- Regulatory strategy & support
- Clinical trial document review, preparation & development support