Two Hats Regulatory Affairs aims to help increase the chance of a green light for your:

• Post Approval variations to Marketing Authorisations
• National, Centralised/Decentralised/MRP Licence renewals & USA FDA annual reports,
• Manufacturing Transfers especially to/from contract manufacturers,
• Clinical Trial Applications (in not more than 2 countries),
• Rewriting/updating Patient Information Leaflets so that patients can actually understand them.

Christopher Hatton looks back on 21 years of experience in biological sciences. He has direct experience in two Clinical Contract Research Organisations and as a Regulatory Conformance Manager at the pan-European level at one of the world largest research orientated pharmaceutical companies and lately as an independent consultant.