We refine, plan, and execute your product development strategy

Understanding the global regulatory landscape is critical for your program, and our Regulatory Strategy and Submissions team has the experience and expertise to develop a regulatory strategy that will ensure the efficient and timely execution of your product development program.

Our regulatory scientists enjoy partnering with clients for the long haul, from early development discussions about a diamond in the rough through to marketing application development, Advisory Committee meetings, and late-stage negotiations with the regulators. Along the way, we leverage our decades of experience with many product classes and therapeutic areas to help you identify the most expeditious and sensible regulatory/development strategy and key gaps, risks, and mitigations to make your program successful.

Considerations for Regulatory Strategy Development

To properly inform, develop, and manage the operational plans and execution of the activities across all disciplines in your development program, your comprehensive Regulatory Strategy should include the following critical components, and should be maintained and revised appropriately as development progresses:

• Target Product Profile, including target indication and key elements of labeling
• Summary of Applicable Law, Regulations, and Guidances (Regional and Global)
• Identification of regulatory pathways in targeted regions and overall Global Submission Strategy, including targeted regulatory submission dates for clinical trial applications and marketing applications, and considerations for relationships and potential synergies among submissions across different regions for a global development program (i.e., strategy for harmonized submission development)
• Assessment of options for accelerated development and approval
• Assessment of approved precedent products, including strategic review of previous regulatory agency approval documents (for example, FDA Summary Basis of Approval, European Public Assessment Report)
• Strategic Assessment of clinical and nonclinical studies required for each phase of development
• Identification of key Go/No-Go decision criteria
• Regulatory Authority meeting plans for scientific/regulatory advice and pre-submission meetings
• Running log of all regulatory authority advice, including all comments, questions, and agreements, and noting any unfulfilled requests
• Regulatory risk management plan (identification and mitigation of key regulatory risks)
• Lifecycle management strategy