Regulatory Support for Clinical Trials
Before commencing a clinical trial on a medicinal product in an EU country, an application for Clinical Trial Authorisation (CTA) must be submitted and approved by the corresponding national competent authority. CTAs in the EU must be supported by a common set of data and core principles; however, some Member States may require additional data or have differences of opinion on the adequacy of CTA data.
How can we help?
We are specialists in the design and regulation of clinical trials. We can advise on clinical and regulatory strategy for new product development, design clinical trial protocols, prepare investigators’ brochures and IMPDs, undertake applications for CTAs and ethics committee submissions. We can carry out GCP audits of investigational sites as well as CROs. Our experts can also handle your pharmacovigilance requirements in connection with clinical trials, and reporting to the appropriate competent authorities.
For a more detailed discussion on how we can help you, contact us on +91 886000 9879 or email us via our contact form