As an established pharmaceutical company focused on neurological diseases prepared for a submission, they realized they hadn’t fully completed necessary GMP and GCP activities. While managing several leadership changes, the company recognized the importance of reviewing and correcting their quality initiatives. It became imperative to address these gaps to ensure compliance and successful program management.
The Solution
BioBridges provided the strategy and hands-on functional expertise necessary to ensure appropriate quality activities were underway to successfully move the program forward.
The BioBridges team provided the following:
- Developed quality programs for the manufacture, packaging, testing, labeling, and distribution of clinical trial material
- Created and implemented systems to assess for process, quality, and regulatory impact
- Prepared the company for the transition from investigational stage to commercial products through CMC development, outsourcing oversight, and the preparation of quality documentation
- Performed oversight evaluations, GMP and GCP quality audits, and mock inspections of third parties, compounding pharmacies, suppliers, systems, and documents to identify and address quality, supply, and data integrity issues
- Triaged deviations, developed investigation strategies, performed quality impact analysis, suggested actionable CAPAs, and recommended appropriate disposition based on manufacturing and laboratory events
- Mentored internal employees in root cause analysis, investigative process, and CAPA development
- Extensively reviewed and corrected GMP actives
The Results
BioBridges used a targeted strategy, quality audits, and hands-on support to guide the client through addressing their quality gaps. This approach ensured the completion of GMP and GCP activities. It also reinforced the company’s ability to meet regulatory standards and follow best practices. As a result, the client filed their submission on time and gained approval. They could then continue advancing their neurological disease treatments. Additionally, the company built a stronger, more sustainable quality management system. This improvement enhanced their program management capabilities and boosted their confidence in managing future regulatory submissions and clinical trials.
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