Quality compliance is crucial for success in the highly regulated pharmaceutical industry, and the importance of this compliance has led to the notion of a quality culture that supports compliance. But what happens when critical business needs and quality compliance demands collide? When stressed by competing priorities, a company’s quality culture may stand up and […]
When Life Sciences Law Firms need to support their clients, they call Compliance Architects®. Founded by Jack Garvey, a leading expert-attorney in FDA-regulated compliance, quality, operations and regulatory matters, Jack possesses close to 30 years of hands-on leadership experience at top-performing life science companies including Johnson & Johnson, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst […]
Global drug/device combination products manufacturer — When one of our clients struggled with enough talent to fulfill a broad remediation plan they promised the FDA, they turned to Compliance Architects®. After quickly scoping their needs and factoring in the company’s “personality” we were able to select the perfect individual to work hand-in-hand with their staff. […]
Client Business Situation See the video of the conference presentation about this case study HERE. Like many regulated life science manufacturers, to proactively reduce risk and focus on continual quality improvement, Bayer Pharmaceuticals’ primary biomanufacturing site in Berkeley, California, engaged in extensive quality and compliance self-analysis during 2015 and 2016. The outcome of this work consisted of […]
Download a . PDF of this Case Study here:Managed Service Solutions for Annual Product Review (APR) Client Business Situation Client was experiencing multiple problems with its Annual Product Review (APR) process for its externally manufactured products, which included OTC Pharmaceuticals, Cosmetics, and Medical Devices (See Note). Client was also exceeding its budget for the execution […]
Download a .PDF of this Case Study here:SharePoint® Quality & Compliance Metrics Reporting Client Business Situation Client was trying to manage a complex enterprise enforcement remediation activity without the benefit of useable information on quality systems’ metrics or quality system effectiveness. Most site quality information was being collected on Microsoft Excel spreadsheets, with much difficulty, […]
Project Title | Success Narrative |
|---|---|
Hospital Network Clinical Compliance Remediation | CA drove the analysis, support, and remediation activities for a large hospital network that had received a Warning Letter for clinical study deficiencies. We guided executive management through critical messaging and response activities and drove remediation to success. |
Biopharmaceutical Manufacturer Executive Training & Quality Culture Assessment | CA helped this pipeline-stage biopharmaceutical developer and manufacturer with comprehensive executive training in quality and compliance and assessed the company’s quality culture with our innovative Quality Pulse® diagnostic methodology. Both projects provided the company with greater confidence across their leadership team and enhanced the foundation for success. |
Radiopharmaceutical PAI Readiness and Risk Remediation | In multiple projects, CA drove rapid, risk-prioritized improvements to developed CMC outputs for a high-profile subsidiary of a major pharmaceutical company. Focus was on PAI readiness requiring significant CMC and process remediation and upskilling in multiple areas. Iterative improvements and assessments with ex-FDA Investigators resulted in successful PAI and readiness for manufacturing success. |
Combination Product Design Control Assessment | CA helped a pharmaceutical company understand and apply design control requirements for a potential combination product and assisted company with understanding 21 CFR Part 4 and its applicability and integration with 21 CFR 820 and 21 CFR 211. Ex-FDA Investigator review of documentation to provide lens of FDA for company. |
Biopharmaceutical GCP, CMC, GMP & QA Support | CA helped a well-funded, early-stage biopharmaceutical company to build out its foundational operational functions, including CMC, GCP, GMP and QA. Scope of work included design and development of systems; development of necessary documents; review and enhancement of product files (CMC); and upskilling and organizational improvements to functional areas. Work resulted in company being acquired and merged into successor organization. |
Biopharmaceutical, Combination Product CMC and PAI Readiness Remediation | CA supported a European biopharmaceutical company with a complex combination product that was expecting a PAI from FDA in a short timeline. CA deployed its CRPN Quality Roadmap® to aggregate and risk-prioritize known gaps and risks, and develop a hard-prioritized quality remediation plan. Additional assessment activities identified significant other gaps and risks. Assistance with remediation improved company operations in the near term to provide additional likelihood of PAI success. |
Pharmaceutical Distributor Writing for Compliance® Training | Large, national distributor of pharmaceutical products sought and received training to improve quality and operational documentation throughout its operations. CA delivered its Writing for Compliance® workshop training program to a mixed complement of operational staff. Feedback scores showed high levels of value and satisfaction. |
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