Regulatory Affairs: Navigating Complex Global Requirements for Product Approval

Regulatory Strategy Development

We create comprehensive regulatory roadmaps tailored to your product's specific characteristics and therapeutic area. Our strategic planning incorporates global and regional requirements while identifying opportunities for expedited pathways and maximizing market access potential.

Health Authority Interactions

We prepare for and manage communications with regulatory bodies including FDA, EMA, PMDA, and emerging market authorities. Our team develops briefing documents, meeting requests, and presentation materials while providing expert representation during health authority meetings.

Regulatory Submissions

We prepare and compile complete submission packages for INDs/CTAs, NDAs/BLAs/MAAs, and supplements/variations. Our submissions incorporate all required technical, administrative, and clinical components while ensuring compliance with eCTD specifications and regional requirements.

Gap Analysis and Remediation

We conduct thorough assessments of development programs to identify regulatory gaps and compliance issues. Our remediation strategies address deficiencies with practical solutions that minimize impact on development timelines and approval prospects.

Regulatory Intelligence

We provide current insights on evolving regulations, guidance documents, and precedents across global markets. Our intelligence monitoring keeps your development program aligned with changing requirements while identifying strategic opportunities.

Labeling Development

We develop compliant product labeling including package inserts, SmPCs, PILs, and carton/container labeling. Our approach balances regulatory requirements with marketing considerations while ensuring consistency across regions.

Post-Approval Maintenance

We manage post-approval commitments, annual reports, and product variations/supplements. Our lifecycle management strategies maintain compliance while supporting product enhancements and market expansion.

Due Diligence Support

We conduct regulatory assessments for potential acquisitions or partnerships. Our due diligence evaluations identify regulatory risks and opportunities while providing strategic insights for business development decisions.