Regulatory Interactions & Submissions

Experience with FDA, EMA, MHRA and PMDA:

What we do

Regulatory interactions

We have experience with FDA, EMA, MHRA and PMDA across the following:

Pre-IND meetings

IND preparation and submission

End of Phase I meetings

End of Phase II meetings

Advisory Board meetings

Type A, B and C meetings

NDA submissions

Post-marketing commitment/requirement discussions