First in Human strategy interactions with Health- Authorities
INTERACT meetings (US)
FIH Clinical trial submissions
Phase 2 study design planning
Clinical Trial Applications
Pivotal trial submissions
Substantial amendment submissions
Drafting Briefing books and leading Type A, B and C meetings
Orphan Drug Applications
Paediatric Investigation plan drafting, submission and compliance
Urgent safety measures
Trial suspension and termination
End of trial notifications
Drafting Briefing books and leading scientific advices
Regulatory Strategy for MAA/BLA/NDA submissions
Pre-submission Authority interactions
Management of EAMS programs
Product Information drafting and manage translations for the EU
Authority Liaison
BLA/NDA/MAA submissions
Regulatory Launch preparations
Support in submissions to other Markets
Post Marketing Commitments/Specific Obligations Regulatory Submissions
PSUR submissions
MAA renewals
Variations and Article 61 (3) preparations
Indication Extension (Type II) variation preparations and submissions
We adapt to our client needs in order to meet their requirements and expectations
We work to deliver high-quality regulatory services
Fully Outsourced Model
Working with clients established vendors to support/execute/deliver to their Regulatory needs.
Providing regulatory solutions across the globe by helping connect client with trusted vendors.
