With so many good FDA quality, regulatory and compliance consultants available, why should you retain Compliance Architects® to assist you with your quality, compliance and enforcement remediation needs? In short, we have extensive experience, top credentials, and provide greater innovation and business acumen than many compliance advisors currently servicing FDA-regulated industry:
- Real-World Experience: We have held senior executive roles in top FDA-regulated companies. We understand the issues facing Vice Presidents of Quality, General Counsel, Chief Compliance Officers, Chief Operating Officers, and the complexities associated with today’s revenue-challenged business environments.
- Builders not Auditors: Unlike many traditional consultants, we haven’t just audited or inspected operations to get our experience — we’ve built complex, functional operational systems that have worked, and that have withstood regulatory scrutiny. We’ve also lived with these systems and understand how difficult it can be to maintain optimal compliance in cost and resource constrained environments.
- Expansive Capability to Complete Assignments: We can operate at a strategic or tactical level. Although many of the deficits in companies’ quality systems are found at a strategic level, eventually you’re going to have to write policies, procedures, validation protocols, batch records, and other supportive documents. By developing the right framework, these will be easier to develop, and will provide greater value to your organization.
- FDA Experience & Insight: We have worked closely with many well-known ex-FDA personnel and understand how the Agency approaches regulated operations, and what they are looking for. However, we also know that no matter how close your relationship is with an Investigator, the best way to achieve great compliance outcomes is to build great compliance architectures.
- Advocacy through Science: We embrace advocacy in our compliance counsel and strategy. It’s imperative that companies present the best message possible when conveying information about their quality systems/compliance architectures. Through innovative approaches to documents, inspection management and response activities, your best image and message will be conveyed to FDA and other regulators.
The Compliance Architects® Difference
In the 34 years since the implementation of the original pharmaceutical cGMPs, 21 CFR Part 211, industry’s approach to FDA compliance has remained largely the same: find discrete compliance problems and fix discrete compliance problems. This “checklist” approach to compliance has in large part resulted in “a culture of CAPA” – one in which the entire focus of large, internal quality organizations (and their even more massive budgets) is spent on fixing the problems that are found during audits, inspections and day-to-day from deviations, non-conformances and CAPAs.
There’s one big problem with this traditional approach to compliance: it does not work. A checklist approach to compliance does not, and cannot, result in sustainable compliance outcomes for FDA-regulated companies. The evidence for this is clear and convincing: industry’s compliance performance record has remained exceptionally poor through the years, with dozens and dozens of Warning Letters and even more FDA 483s issued to FDA-regulated companies each year.
Compliance Architects® was founded on the belief that a different approach to compliance is required – one that focuses on designing and building (or often, remediating) the core, structural elements that are essential for sustainable compliance. This approach, which is core to our branding as “Compliance Architects” is embedded into all aspects of the work we perform for clients. Our approach has been extraordinarily successful – call us or read our case studies to find out for yourself how our clients feel about our work.
How We Approach Our Assignments
The role of a traditional architect is to create visual representations of new or renovated buildings based on the building’s purpose and function; and to develop integrated plans for construction and commissioning. Our job as Compliance Architects® is similar: we help FDA-regulated companies visualize their unique business model, and define how to overlay and integrate the requirements and expectations of the US FDA for that business model. Then, we develop (and help execute on) the plans and efforts necessary to achieve a compliant, effective business operating model.
Today’s compliance challenges are complex. Effectively and consistently delivering superior compliance outcomes requires expertise and capability in law, regulation, science, business, organizational design, engineering, program management, and risk management, to name just a few. Compliance Architects® is comprised of top experts that have served long tenures within FDA-regulated industry. We evaluate assignments to determine fit to need to ensure your organization is represented by the best, most capable experts in the industry. We bring together the top experts in the field to analyze and resolve your compliance architecture challenges quickly, comprehensively and systematically.