When facing complex regulatory, quality, or clinical challenges, you need more than technical expertise—you need a partner who understands both the urgency of your timeline and the importance of getting it right the first time. Whether it's responding to FDA observations, implementing new quality systems, or preparing for critical inspections, success demands experienced teams who've been there before.
Our consulting model goes beyond traditional approaches. We don't just provide resources; we deliver complete solutions. With dedicated project management, clear milestones, and teams that include 250+ former FDA officials, we bring unmatched expertise to every engagement. Our 95% success rate in providing the right resource the first time and 97% client satisfaction speak to our ability to execute even the most challenging projects.
From rapid-response remediation to multi-year transformations, our consulting teams have successfully completed thousands of projects across every area of life sciences compliance. We understand that your projects aren't just about checking boxes—they're about protecting your products, your patients, and your business.
Access to outsourced resources accelerates the completion of project tasks.
Cut overhead and secure competitive rates.
Lift the constraints of an internal team to utilize skills and competencies from experienced third-party professionals.
Professional oversight makes sure milestones are met.
Our network includes 250+ former officials who know exactly what regulators expect.
Find and fix compliance gaps before regulators do. We help you turn inspection anxiety into confidence with comprehensive audits and realistic mock inspections led by former FDA investigators. We know exactly where regulators look, what triggers observations, and how to prepare your team for success.
Our services include, but are not limited to:
When quality systems break down, every day counts. Our remediation teams—including former FDA officials who've issued the very observations you're addressing—know how to quickly stabilize situations while building long-term solutions.
Our services include, but are not limited to:
Regulatory submissions determine your product's fate. Our teams include former FDA reviewers who understand evaluation criteria, know how to position applications for success, and can navigate complex regulatory pathways efficiently.
Our services include, but are not limited to:
Validation projects demand technical expertise, regulatory knowledge, and practical implementation skills. Our validation specialists bring all three, ensuring your processes, equipment, and systems meet requirements while enabling efficient operations.
Our services include, but are not llmited to:
Whether starting from scratch or transforming existing systems, our QMS experts create quality management frameworks that satisfy regulators while supporting your business objectives. We help you build quality infrastructure that scales.
Our services include, but are not limited to:
Some projects don't fit standard categories but demand specialized expertise. Our deep bench of specialists can tackle virtually any compliance challenge.
Our services include, but are not limited to:
