As an established pharmaceutical company focused on neurological diseases was preparing for a submission and realized that they had not fully completed the necessary quality GMP and GCP activities during the course of the program. As the company adjusted to several management changes, reviewing and correcting their quality initiatives became imperative.
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
Our client was able to file their submission and ultimately gained approval.