Case Studies: #1
Multi-region submission for remodelled container closure systems.
Proposed sweeping changes to container closure systems of several biologics within a manufacturer's portfolio were scheduled across global markets. Our team was hired to advise on quality and safety regulatory requirements in each target region, as well as contribute in developing technical product dossiers that captured necessary stability tests. Over several months, we interacted with various health authorities, coordinated timelines and diligently laboured to bring these products to their milestones.
Case Studies: #2
Post-approval amendments to a manufacturing batch size
The batch size limit of a manufacturing line for approved medicines was tripling in size and required several mandatory reports to the FDA and EMA. We were hired to assess all aspects of this change's impact to product quality and advise on operational tests. Leveraging our CMC experience, we provided clear advice and detailed action steps to pursue, while offering assistance in compiling and submitting reports to health authorities.
Case Studies: #3
Root cause analyses (RCA) for an adverse event
Engaged as independent observers by a Quality team, we offered insights into regulatory reporting responsibilities for drug-related adverse events. We collaborated in developing diagnostic tools to investigate known data from the location of an adverse event and also provided clinical expertise in drug-drug interactions.
