- Real-World Experience
- Builders not Auditors
- Expansive Capability to Complete Assignments
- FDA Experience & Insight
- Advocacy through Science
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, and 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 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 will have to write policies, procedures, validation protocols, batch records, and other supportive documents. Developing the proper framework will make it easier to create and provide your organization with more excellent value.
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 seek. However, we also know that no matter how close your relationship is with an Investigator, the best way to achieve excellent 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 the FDA and other regulators.
The Compliance Architects® Difference
In the over forty years since the implementation of the original pharmaceutical cGMPs, 21 CFR Part 211, the industry’s approach to FDA compliance has mainly remained 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.
One big problem with this traditional approach to compliance is that 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: the 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 essential for sustainable compliance. This approach, which is core to our “Compliance Architects” branding, is embedded into all aspects of our work for clients. Our system has been extraordinarily successful – call us or read our case studies to determine 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) 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 comprises top experts who have served long tenures within the FDA-regulated industry. We evaluate assignments to determine fit to need to ensure your organization is represented by the industry’s best, most capable experts. We bring together the top experts in the field to analyze and resolve your compliance architecture challenges quickly, comprehensively, and systematically.
Our Guiding Principles
At Compliance Architects®, we approach work. We don’t look at work as a game — something to keep score about — we look at it as a noble calling to help the world’s best organizations improve or, sometimes, to get healthy. We understand that even the best companies have challenges and that our ability to help them overcome them is a unique opportunity. Since our approach to work is essential to our clients’ successful outcomes, everyone on our team must understand our guiding principles:
- Always keep our clients’ interests in mind.
- Always have our consultants’ interests in mind.
- Say what needs to be said, even if it’s complex or challenging for a client to hear.
- Deliver value – consistently.
- Manage projects tightly, as if the money being spent were our own.
- Innovate with our solutions.
- Don’t follow, lead.
- Everything matters – especially the details.
- Don’t apologize for making a fair profit.
- Have fun while working hard; the two are not mutually exclusive!
Our vision is clear: To be the most trusted and valued partner for regulated life sciences businesses by architecting differentiated solutions and delivering sustainable quality, regulatory, and compliance outcomes. By adhering to these principles, we believe we get closer to achieving our vision one engagement at a time.
Our Mission Is Simple
To be the world’s most-respected FDA compliance consulting firm. We accomplish our mission one engagement at a time by adhering to these principles.