As part of preparing for commercial readiness, a Phase 3 biotech client faced a pivotal challenge: expanding into the European Union while meeting critical regulatory filing and inspection requirements. Their internal regulatory team was well-versed in U.S. requirements but lacked specific expertise in EU Module 3 expectations, centralized procedures, and regional submission strategy.
The challenge:
- Align global CMC strategy with EU-specific regulatory requirements
- Prepare core components of the EU MAA dossier
- Coordinate with EU-based consultants and Health Authorities
- Avoid delays to the planned commercial launch timeline
To close this gap, Assurea identified and placed a Regulatory CMC Lead from our trusted expert network—someone with direct experience supporting EU filings and commercial readiness. Through our targeted recruitment and SME-led screening process, we ensured the selected expert could immediately contribute to the client’s regulatory strategy. The role was filled within two weeks and quickly integrated into cross-functional teams.
Within the first 30 days, the following was accomplished:
- A gap analysis was conducted between existing U.S. CMC content and EU requirements
- A roadmap for Module 3 preparation specific to EMA expectations was developed
- Coordination was initiated with EU-based regulatory consultants and Qualified Person (QP) resources
- Stability and specification alignment issues critical to EU release requirements were identified and addressed
This targeted support enabled the client to:
- Stay on track with their planned MAA submission timeline
- Confidently engage with EMA and local regulatory partners
- Lay the foundation for a compliant EU commercial launch strategy
This use case reflects how strategic, short-term expertise can bridge critical knowledge gaps at just the right moment. For biotech companies navigating complex milestones—especially across global markets—targeted functional leadership can accelerate progress without compromising quality or compliance.