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Built by auditors, for the teams who answer to regulators.
Pharma Compliance RX exists to give pharmaceutical companies a compliance partner they don't have to double-check — a global panel of specialists who write audit reports the way an inspector reads them.
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- info@pharmacompliancerx.com
Our StoryStarted with one question: why does audit quality vary so much?
Pharma Compliance RX was founded in Ahmedabad in 2023 by a small group of GMP auditors who had spent their careers on both sides of the inspection table — some as in-house quality leads, others conducting audits for global regulators. They kept running into the same problem: a facility could pass one auditor's review and still fail a client's own site qualification, simply because the two reports were written to different standards.
We built the company to close that gap. Rather than hiring generalist consultants, we assembled a panel of specialists — each with 12 to 35 years in a specific therapeutic area, dosage form, or regulatory jurisdiction — and gave them one shared standard for how a finding gets documented, scored, and closed out.
150+ clients, 30+ countries
Grown entirely through referral from quality and regulatory affairs teams who reused us for their next site.
Today that same panel supports companies ranging from single-site generics manufacturers preparing for their first FDA inspection to multinational groups running ongoing third-party audit programmes across a dozen markets. What hasn't changed is the standard: a report we'd be comfortable putting in front of any inspector, anywhere.
150+
New Clients Onboarded
30+
Countries Audited In
35
Years, Top Consultant Expertise
4
Core Service Lines
What We Stand ForThree commitments that shape every engagement
These aren't values on a wall — they're the criteria we use to staff a project and sign off a report.
Headquarters
Regulator-grade rigor
Every finding is written and scored the way it would need to hold up in front of the FDA, EMA or a WHO inspector — not softened for the client reading it.
Consultant Coverage
The right specialist, not the nearest one
We match your audit to a consultant with matching therapeutic, dosage-form and jurisdictional experience — even if that means bringing someone in from another region.
Consultant Coverage
We stay until CAPA is closed
An audit isn't finished when the report ships. We track corrective actions through to close-out so the file is ready for your next inspection, not just this one.
How We've Grown
From a founding panel to a global
consultant network
A short history of how the company scaled without diluting the standard it was built on.
Founded in Ahmedabad
A founding panel of GMP auditors and regulatory specialists forms Pharma Compliance RX, built around a single shared audit standard.
First 50 clients, first 10 countriest
Word-of-mouth referrals from quality and regulatory affairs teams take the consultant panel from single-site engagements to multi-country audit programmes.
Regulatory services & quality compliance added
Client demand for ongoing support — not just point-in-time audits — leads us to formalise regulatory filing support and quality management system consulting.
150+ clients across 30+ countriest
The consultant network now spans specialists with 12 to 35 years of experience, positioned to deliver credible, regulator-acceptable work wherever a client operates.