End-to-End Pharma
Delivering complete Validation, Qualification, Documentation, Regulatory Affairs, Audits & Training services — a comprehensive solution.
about primegmp
Your Partner for Trusted GMP Consulting and Compliance
PrimeGMP helps pharmaceutical and healthcare companies achieve strong, audit-ready quality systems. We deliver expert-led validation, qualification, documentation, and regulatory support aligned with WHO, USFDA, EU, MHRA & PIC/S expectations. ✔ End-to-end GMP solutions ✔ Fast, accurate, audit-ready documentation ✔ Compliance made simple
our services
Best Solutions For Your Business
Qualification
Comprehensive DQ/IQ/OQ/PQ qualification ensuring equipment, utilities, and facilities meet all cGMP regulatory requirements.
Validation
End-to-end process, cleaning, method, and CSV validation supporting lifecycle compliance and robust manufacturing operations.
Documentation
Development of SOPs, validation documents, templates, and controlled records aligned with global GMP documentation standards.
Training
Specialized technical training on GMP, QMS, validation, data integrity, and aseptic practices for workforce capability enhancement.
Marketing Auth./ Regulatory Affairs
CTD/eCTD dossier preparation, product registration support, and regulatory submissions for national and international markets.
Engineering / Project Designing
GMP-compliant facility layout design, URS preparation, equipment selection, and technical project support for new installations.
Audit & Consulting
Comprehensive GMP audits, compliance evaluations, and gap analysis with corrective strategies for regulatory inspection readiness.
Thermal Mapping
Precision temperature and RH mapping for warehouses, chambers, cold rooms, and logistics to ensure controlled environments.
Our Valuable Clients
Why Choose Us
Proven GMP Expertise
Our team brings deep technical knowledge across validation, qualification, audits, regulatory affairs, and compliance for pharmaceutical and healthcare operations.
Aligned With Global Standards
We ensure your systems meet WHO, USFDA, EU, MHRA, EMA, and CDSCO expectations through globally accepted, audit-ready approaches.
Tailored, Practical Solutions
Every facility is unique—our solutions are customized, risk-based, and designed to fit your processes without unnecessary complexity.
Complete End-to-End Support
From system design and documentation to audits, approvals, and regulatory submissions, we support your entire compliance lifecycle.
TESTIMONIALS
What Our Clients Say About Us
Our clients trust us for our commitment, expertise, and results. Their words reflect the quality of our work and the relationships we build.
Ravisen Sharma, GM–Quality
Zeiss Pharma Limited
PrimeGMP has been a strong partner in elevating our quality and compliance systems. Their technical expertise in validation, qualification, regulatory alignment, and airflow visualization (smoke studies) has greatly strengthened our operational robustness.
Dinesh Singh
General Manager (Plant)
PrimeGMP has strengthened our plant with dependable qualification, validation, and GMP documentation support. Their regulatory expertise in dossier preparation and submissions makes them a trusted partner for smooth approvals
Adesh Sharma Asst. Manager – QA
Amnos Lifesciences
PrimeGMP has consistently supported us with accurate documentation, qualification, validation, and dossier-related deliverables. Their clarity, speed, and GMP-focused approach greatly enhance our QA effectiveness.”
We Always Try To Understand
Users Expectation
PrimeGMP Solutions LLP delivers reliable GMP consulting, qualification, and compliance support to strengthen your operations and regulatory readiness.
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Contact
info@primegmp.com
+91 6280308573
523A, Diamond Avenue, Majitha Road, Amritsar, Punjab, India
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