With so many good FDA regulatory and compliance consultants available, why should you retain Compliance Architects® as your preferred compliance advisor? 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 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’ve 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.