Quality Assurance assures that products have appropriate characteristics of “safety, identity, strength, quality, and purity.”
At BioBridges, our QA consultants develop, execute, and report on quality (GxP) processes, from product manufacturing and preclinical research to clinical research. For medical quality assurance and pharmaceutical quality assurance, our consultant’s typical functions include:
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.
An emerging oncology company that relied heavily on outsourcing was moving into phase 3 of their first clinical program. They needed a plan and processes to develop and sustain proper oversight of key functional areas of their phase 3 program to prepare for a successful marketing submission and for future programs in their pipeline.
Read MoreA large, established pharmaceutical company was planning to submit a new drug application for a biological product to treat a rare disease. Concurrently, the company was working through a variety of corporate initiatives that—while positive—were impacting productivity, including corporate restructure, headquarters relocation, and several acquisition integrations.
Read MoreAs 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.
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