Pre-authorisation

Before submitting a marketing authorisation application, there are a number of key processes to undertake which will influence the requirements and subsequent direction of your new product takes. Most importantly, completion of these obligations will help ensure successful approval by the regulators.

How can we help?

We pride ourselves in our ability to support clients through the pre-authorisation phase. Our experts can help optimise your development programme to ensure you are fully aware of all of the requirements you need for a positive regulatory outcome.

For a more detailed discussion on how we can help you, contact us on +91 886000 9879 or email us via our contact form