We didn't just follow the FDA's guidance.
We helped write it.
Compliance Group's executives were key contributors to the FDA's Computer Software Assurance guidance: FICSA co-founders behind what your auditors reference. For 25 years, we've helped 60+ life sciences organizations navigate the most complex compliance challenges in the industry. We built CLAiRE AI Agentic Platform because the tools we needed didn't exist yet.
Built from the audit room. Not the boardroom.
Compliance Group was founded on a simple observation: the life sciences compliance industry was full of firms that delivered documents. Very few delivered programs: the kind that hold up over time, scale with the business, and transfer knowledge instead of creating dependency.
Our founders came from inside regulated organizations. They'd been in the audit rooms. They understood what defensible compliance evidence looked like, and what it didn't. They built Compliance Group to deliver the kind of expertise that most consulting firms couldn't: deep GxP knowledge, FICSA co-founder credentials, and a delivery model designed for the US middle market.
Twenty-five years later, 95% of new business still comes through referrals. When an engagement ends, the client's team is more capable. That's the standard we hold ourselves to across 60+ regulated life sciences organizations on multi-year programs. We transfer.
Libertyville, IL 60048
Charlestown, Boston, MA 02129
The credentials that distinguish us from every other life sciences compliance firm.
Key contributors to the FDA's CSA guidance
Our Executive Vice President chairs the FDA–Industry Computer Software Assurance Team (FICSA). We were key contributors to the CSA guidance that replaced legacy CSV as the FDA's standard. When we design validation programs, we're working from the same framework the FDA uses to evaluate them.
ISPE GAMP 5 Second Edition co-authors
Our team served on the ISPE GAMP 5 Second Edition steering committee. The validation methodology we apply — and that CLAiRE AI Agentic Platform encodes, which is the same one GAMP 5 defines as the industry standard.
Only ISO/IEC 42001-certified AI MS in life sciences compliance
We built CLAiRE AI Agentic Platform under ISO/IEC 42001 before we built our clients' programs. Six capabilities, one certified platform, with every output explainable, traceable, and audit-ready.
Triple-certified: ISO 42001 + SOC 2 + ISO 27001
The complete trust framework for organizations evaluating compliance partners with access to their regulated systems and data. Independently audited. Not self-certified.
300+ GxP systems validation knowledgebase
Validation packages and playbooks refined over 25 years of real inspections. Included in every managed services and implementation engagement, not sold as add-ons. No build-from-scratch.
Zero major audit observations — committed
We don't just claim inspection readiness. We commit to zero major audit observations across all managed programs — with no-cost remediation if we fall short. 60+ regulated life sciences organizations hold us to it.
ISO/IEC 42001: 2023 Certified
Ethical and Well-Governed AI Secure, Transparent & Accountable Systems Scalable, Trust-Driven Innovation
SOC 2 Type 2 Compliant
Independently audited controls Proven operational effectiveness Security, availability & confidentiality assured
ISO/IEC 27001:2022 Certified
International information security standard Risk-based security management system Strong data protection & governance
SOC 2 Type 2 Certified
The team behind the guidance.
Sarat Bhamidipati
Sarat founded Compliance Group on the principle that compliance expertise should transfer, not create dependency. Under his leadership, Compliance Group has grown to serve 60+ regulated life sciences organizations. He leads Compliance Group's commercial strategy and technology vision for CLAiRE AI Agentic Platform.
Khaled Moussally
Khaled chairs the FDA–Industry Computer Software Assurance Team (FICSA) and was a key contributor to the FDA's CSA guidance. With 25+ years of GxP compliance experience, he leads Compliance Group's strategic consulting, AI governance practice, and the CLAiRE AI Agentic Platform development program.
ISO/IEC 42001:2023 · SOC 2 Type 2 · ISO/IEC 27001:2022
ISO/IEC 42001:2023 Certified
The only ISO/IEC 42001-certified AI Management System in life sciences compliance. Every AI recommendation is explainable, traceable, and audit-ready.
SOC 2 Type 2 Compliant
Independently audited controls. Proven operational effectiveness. Security, availability & confidentiality assured.
ISO/IEC 27001:2022 Certified
International information security standard. Risk-based security management. Strong data protection for regulated environments.
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