By Dawn L. Wofford, Cytovance Biologics
Navigating product development is inherently difficult. Ambiguous global regulations and complex submission requirements make questions and challenges inevitable. Because regulatory requirements and GMP expectations increase as product development proceeds, many biopharmaceutical manufacturers wait until late stages to make Good Manufacturing Practices (GMP) a priority.
By integrating GMP this way, manufacturers attempt to increase speed to market and reduce overhead. However, waiting to implement GMP frequently leads to significant operational challenges, as both the FDA and EU gives the ability to be flexible during Phase I, increasing requirement stringency for Phase II and Phase III processes. Accordingly, as manufacturers move their product from research to clinical phases, these requirements often become a bottleneck, potentially impacting commercial timelines and inflating budgets. Further, it has become increasingly difficult to maintain a uniform interpretation of regulatory norms in recent years, at both the corporate and industry levels.
By taking a strategic, proactive approach to regulatory and process development, you better position your organization to avoid unexpected challenges. Here, we will provide three key steps you can take to implement a regulatory framework to the highest standards.