Global Regulatory Affairs and Medical Writing

Global Regulatory Affairs and Medical Writing

Accelerate Approvals with Strategic Regulatory Leadership and Execution

We understand drug development from beginning to end and take a holistic approach to guiding your program forward by providing these core regulatory affairs capabilities:

Strategy: Global Regulatory Affairs provides the overall strategy, oversight, coordination and reach for global clinical development

Publishing: Dedicated Regulatory Publishing experts compile, electronically publish and submit any Regulatory document required, in accordance with local regulations

Relationships: Global Regulatory Affairs and Subject Matter Experts manage Agency guidance and scientific advice meetings to facilitate actionable project progress leading to approvable submissions

Review and Planning: Global Subject Matter Experts provide experienced and nuanced review and strategic advice on pre-clinical, pharmacology, and CMC elements of your program

Review and Planning: Global Subject Matter Experts provide experienced and nuanced review and strategic advice on pre-clinical, pharmacology, and CMC elements of your program

Medical Writing: Degreed professionals prepare expert protocols and clinical study reports, and conduct thorough literature reviews and document preparation