Regulatory Support

Regulatory Support

In many instances, before making investments, it is advisable to take scientific advice from relevant regulatory authorities. Controlled correspondence is an effective way to make a request, submit changes or obtain clarification on specific information from regulators. An adherence to applicable guidance’s and addressing the issues clearly while writing controlled correspondences increases chances of accepting the request and getting specific and speedy response from the authority on requested query.

Our experienced team supports you in regulatory concerns, approvals and relevant documentation during pre- and post-study submissions which includes the following:

• Controlled correspondence with regulatory authority.
• Any regulatory inquiry response and justification
• Biowaiver Applications