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.
At BioBridges, we have highly skilled consultants with extensive experience in the biotech, pharmaceutical, and medical device industry. With a wide range of expertise, these life science consultants are incredibly well suited to step in and immediately provide valuable contributions to your development programs. Whether you are an emerging start-up or an established company, looking for individuals or functional teams, BioBridges' consultants provide guidance and support to accomplish the objectives across all areas of clinical development. You can accomplish the work with experienced professionals whose passion is to focus on programs that inspire them, move important work forward, and make an impact. Engaging BioBridges gives you the ability to accomplish the work at hand.
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