Improving on Regulatory Success & Reducing Cost with Aligned Data Sets that Allow for Expansion into Global Markets
- Discuss how harmonized global data packages provide the opportunity to streamline regulatory submissions and reduce duplication of costly regional studies
- Identify that the first critical step to aligning across jurisdictions is to develop standardized datasets based on a comprehensive overview of fermentation processes, QM/QA/QC parameters, and product specifications
- Participate in proactive dialogue with regulatory authorities to fully describe product composition, innovations in product fermentation and formulation to develop crossborder datasets that support scalable regulatory and commercialization strategies for new territories