GMP Compliance & CQV Services

Precision in
Compliance.
Excellence in Quality.

Connecting pharmaceutical manufacturers with the expertise needed to achieve regulatory readiness, GMP compliance, and audit success — from greenfield projects to global API units.

28+ Years of Experience
FDA MHRA · WHO · TGAA
GMP Audit Readiness
What We Do

GMP Compliance, Built Around Your Project

We work with pharmaceutical manufacturers to create compliant environments and achieve accreditation from international and local regulatory authorities.

Green & Brown Field Projects

End-to-end GMP support for new facility builds and upgrades to existing pharmaceutical manufacturing sites.

  • New facility GMP setup
  • Existing site upgrades
  • Regulatory gap analysis
CQV Services

Commissioning, Qualification, and Validation services ensuring all equipment and systems perform as intended under GMP.

  • Equipment qualification (IQ/OQ/PQ)
  • Utility qualification
  • Process & cleaning validation
Audit Readiness

Prepare your facility for inspections from global agencies with expert-led mock audits and remediation guidance.

  • FDA, MHRA, WHO, TGAA prep
  • Facility & vendor audits
  • CAPA management
Documentation & Systems

Strong, audit-ready documentation from SOPs and VMPs to Site Master Files and full quality system upgrades.

  • SOPs & philosophy documents
  • Site Master File / VMP
  • Quality system upgradation
Our Expertise

28 Years of Regulatory Excellence

Deep operational experience across India's leading pharmaceutical manufacturers and international regulatory environments.

Strategic Guidance

Direction and advisory on quality systems and GMP compliance structured to succeed in regulatory and global audits across international markets.

Documentation Execution

Comprehensive documentation covering specifications, STPs, artworks, process & cleaning validation protocols, equipment qualification, and stability study protocols.

Global Regulatory Readiness

Establishment and readiness for inspections from FDA, MHRA, TGAA, WHO, and EU — for commercial formulation plants and global API projects in India.

International & Domestic

Track record across both international and domestic pharmaceutical companies in India, with hands-on experience in formulation and API manufacturing units.

Services

What We Deliver

PR Pharma Consultancy provides targeted, hands-on consulting across the full spectrum of GMP compliance activities. Whether you need to build your quality infrastructure from scratch or prepare for an upcoming regulatory inspection, our team brings operational expertise, not just advisory.

Every engagement is tailored to your site's specific needs, regulatory landscape, and timeline — with a focus on lasting compliance, not just passing the next audit.

Discuss Your Requirements
Documentation
SOPs
Layouts Review
Philosophy Documents
Site Master File
VMP Preparation
Equipment Qualification
Utility Qualification
WHO Audit Readiness
EU Audit Readiness
FDA Audit Readiness
Training Programs
Process Validation
Vendor Audits
About the Founder
Piyushkumar Raval
Founder & Principal Consultant

With over 28 years of hands-on experience in quality assurance and GMP compliance at leading international and domestic pharmaceutical companies, Piyushkumar brings deep operational knowledge to every engagement. His work spans strategic guidance on quality systems, execution of complex validation programs, and direct support for regulatory inspections from global agencies including FDA, MHRA, WHO, and TGAA.

Contact

Get In Touch

Ready to achieve compliance and regulatory confidence? Reach out to discuss your project requirements.

Location
Olive Greens, SG Highway, Ahmedabad — 382481, Gujarat, India