Client Business Situation This client company was a long-established, family-owned, manufacturer of dietary supplements and OTC pharmaceuticals, with a long, and unfortunately poor history of compliance with the US FDA. The company had also been experiencing problems with customer fulfillment and product quality. Client Business Pain After a particularly aggressive FDA inspection, the client received […]
Client Business Situation Client was a long-established manufacturer of class II durable medical devices designed for mobility assistance. Due to challenging competitive and other market conditions, client had made a decision within the last five years to move manufacturing from a domestically-based operation to an overseas contract manufacturer. Client Business Pain Significant FDA enforcement action […]
Client Business Situation Client Company had experienced multiple enforcement interactions with the US Food and Drug Administration in its recent history. As a result of a number of specific, related enforcement activities, client’s business operations were being significantly impacted with revenue and profitability down sharply. When Client Company initially approached Compliance Architects® for assistance, it […]
Client Business Situation AFHCAN (Alaska Federal Health Care Access Network), an organizational unit of the Alaska Native Tribal Health Consortium (ANTHC) is an organization dedicated to improving the healthcare delivery of the native Alaskan population through a diversified healthcare delivery model. AFHCAN, as part of its overall mission, has developed innovative and proprietary medical device data systems (MDDS) […]
Client Business Situation Client was a large physician practice group with a substantial clinical study practice. Due to the nature of the studies conducted and association with significant pharmaceutical company clinical trials, FDA conducted an inspection of the practice location and conduct of individual clinical studies. This was the first experience the practice had with […]
Client Business Situation A leading high-volume manufacturer of consumer medical devices located outside of the United States was experiencing increased concern regarding their regulatory compliance enforcement profile. Factors contributing to this increasing concern included strong enforcement actions at a sister division and known deficiencies in multiple aspects of the company’s quality systems identified through internal […]
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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