Regulatory Strategy and Consulting

The regulatory strategy serves as the foundational document guiding drug development and market entry. It provides a clear outline of the pathways for drug approval, key milestones, and regulatory requirements at different stages. This strategic document offers actionable directions and steps for cross-functional teams. When formulating regulatory strategies, it is crucial to comprehensively consider risks and challenges in areas such as Chemistry, Manufacturing, and Controls (CMC), non-clinical and clinical regulations. Changes in one area may significantly impact others and, consequently, the overall development plan. It is essential to proactively anticipate the potential impact of regulatory changes and ensure that our strategies align with these changes. As accumulated research data and external conditions evolve, continuous updates to the strategy are necessary to ensure smooth product development and market success.

Humphries's consultant team comprises former senior FDA/CDE officials, review experts, and professionals from various specialized fields. Based on your business objectives and specific needs, Humphries provides regulatory strategy consultations and comprehensive solutions, including but not limited to the following areas: