By drawing on innovative thinking that stretches boundaries and a solid regulatory foundation and sound understanding of clinical development, we advise clients on the optimal regulatory approach in support of their strategic business objectives.
Strategic Regulatory Guidance
Regulatory Intelligence
New or revised regulations and guidance documents are reviewed and information most relevant to your regulatory strategy is identified. We help you truly understand the regulatory environment and guide you through the evolving drug development landscape.
Regulatory/Scientific Due Diligence
We provide an independent medical expert/scientific review of the scientific data supporting the regulatory application. Identifying gaps in the supporting data can pre-empt potential timely and costly obstacles during the review and approval of the application.
Government Liaison
Understanding and developing solid relationships with regulatory authorities is just as important as the quality of the scientific data. We are experienced in the preparation of high-quality meeting/briefing packages and can help you plan for meetings with regulatory authorities.