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Regulatory Affairs

Our seasoned, responsive team is pleased to provide a wide range of strategic and operational Regulatory services. Ensure you are taking advantage of opportunities and avoid pitfalls. Save time and money by minimizing risks and building and implementing the right strategy.

 

Global and Local Regulatory Strategy 

State of the Art electronic submission publishing

US Agent with the US FDA on behalf of Sponsors

Investigational New Drug Applications

New Drug and Biologics Applications

Abbreviated New Drug Applications

Orphan Product Applications

Breakthrough Therapy Applications

QIDP and Fast Track Designation Requests

Pediatric Strategies in ICH Regions

Health Authority Meetings in ICH regions

Meeting Briefing Packages

IMPDs, CTAs, MAAs, Variations

PRIME, Adaptive Pathways

FDA Advisory Committee Project Oversight

Product Labeling and Launch Support

Lifecycle Management

working together to effectively navigate the regulatory landscape