Two Hats Regulatory Science GbR 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,
• Phase  I/II Clinical Trial Applications (in not more than 2 countries),
• Parallel import applications
• Legalisation (consulate/chamber of commerce etc.) of key regulatory documents.

We also offer:

• Review of your scientific articles,
• Interim management,
• Mentoring of new staff.

more about our services»

 XING

With our combined laboratory based research, coupled with our clinical development and manufacturing site experience we aim to provide honest ethical support for your projects.