Strategic Regulatory Affairs

When you need regulatory affairs to go beyond mere compliance, THINK THEOREM.

In early development, some companies view regulatory affairs as a function that is solely about compliance: preparing, submitting and maintaining applications; submitting adverse event reports; and coordinating routine communications with regulatory agencies. At Theorem Clinical Research, we feel this approach misses an important opportunity to use regulatory affairs strategically to reduce development costs, smooth the development path and improve post-approval marketing potential.

Starting well before clinical trials are initiated, Theorem's Strategic Regulatory Affairs (SRA) specialists do the work necessary to understand both the regulatory landscape and relevant precedents. Early regulatory guidance in these areas can build a framework for the overall development plan and help determine the fastest path to market that offers the greatest value. Strategic regulatory planning helps develop the scope of nonclinical, technical and clinical testing that will be required for registration.

Theorem's regulatory strategists have strong regulatory and scientific backgrounds that allow them to provide strategic regulatory solutions for clients' products at all stages of development in the product life cycle. Our regulatory expertise includes medical devices and drug-device combination products as well as drugs, biologics and biosimilars, and our professional staff is strategically located around the world with local regulatory expertise available in each country. Regulatory services are included within full-service clinical programs and are also available on a contract basis.

Extensive experiences in leading submission teams and strong working relationships with regulators have enabled us to build a proven track record of successful development and approval of numerous product classes. Working with small, large and virtual companies, our team can help design the right development strategy to achieve your goals whether that is a full development program or helping build value at a single stage of development to support an out-licensing strategy.

Strategic Regulatory Affairs Services

• Regulatory Consulting
• Drug Development Strategy
• Authorized Regulatory Liaison
• Guidelines and Precedents Analysis
• Submission Design and Execution in All Formats
• Product Label Claim Optimization
• Global Submission Strategy
• Regulatory Risk Analysis of Essential Documents for Product Release