Formulation development — including preformulation and analytical — is another crucial aspect of early-stage pharmaceutical product development, ensuring compatibility with manufacturing processes and scalability. For example, a poorly chosen excipient or process can pose significant hurdles to regulatory approval.
A well-structured regulatory strategy is essential, particularly for inexperienced organizations. It provides clarity on objectives, required resources and the intended regulatory pathway. Open communication with regulatory agencies throughout this phase facilitates a smoother proposal process and regulatory approval.
Early-stage pharmaceutical product development is iterative, involving continuous refinement based on emerging data and insights. It also requires adaptability to changing disease prevalence, treatment paradigms and patient needs.
Join this webinar to gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like contract development and manufacturing organizations (CDMOs) is essential.
Join Srinivasan Shanmugam, PhD, Executive Director, Pharmaceutical Sciences, Business Support, & New Technologies, Adare Pharma Solutions, for the live webinar on Monday, November 13, 2023, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Early-Stage Pharmaceutical Product Development to Reach the Clinic Faster.
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