Because Every Market Deserves World-Class Quality
At Major Healthcare, GMP is not an afterthought — it’s the foundation of everything we do. Whether you’re preparing for WHO or EU-GMP certification, launching a new facility, or managing ongoing inspections, our team provides full-spectrum compliance solutions tailored to the needs of emerging market manufacturers.
We help you align your systems with global standards (WHO, EU, USFDA, PIC/S), from design to documentation to day-of inspection.
Be inspection-ready, every time.
We conduct full mock audits and walk-throughs simulating actual inspections (WHO, EU-GMP, MOH), identifying gaps and risks before auditors do. Our experts support you through CAPA planning, documentation reviews, and staff coaching — ensuring your facility meets global compliance expectations confidently and efficiently.
Build a quality system that scales with your business
From SOP creation to change control and batch documentation, we help design a QMS that supports consistent operations and audit-ready traceability. Our approach ensures data integrity, risk-based validation, and regulatory alignment — built for day-to-day performance and global inspections.
Stay audit-ready all year long.
Our retainer-based service provides recurring support to maintain continuous GMP compliance. This includes internal audits, deviation investigations (OOS/OOT), CAPA tracking, and document version control. Think of it as your on-demand QA support team — scalable to your size and budget.
Strengthen your team’s compliance mindset.
We offer hands-on and role-specific training for QA/QC staff, production supervisors, documentation teams, and leadership. Topics include GMP fundamentals, data integrity, deviation management, and audit behavior. Our train-the-trainer model builds internal expertise for long-term success.
Get your paperwork right — the first time.
We prepare and review critical documentation like Site Master Files (SMF), validation protocols, and GMP annexes. Whether you’re submitting for WHO prequalification, regional GMP recognition, or local MOH registration, we ensure your documents are inspection-ready and regulator-friendly..
Design compliance into your facility.
We help ensure your production spaces follow proper GMP zoning, material/personnel flow, and contamination control. Our team also develops equipment URS, and manages IQ/OQ/PQ protocols to qualify your systems for regulatory approval, especially in sterile and cleanroom environments.
Your GMP compliance is only as strong as your suppliers
We conduct audits of your raw material and packaging vendors, evaluate third-party manufacturers, and establish supplier qualification procedures. Our programs map risks across your supply chain and ensure full traceability and documentation compliance.
Industries We Support
- Generics & biosimilars
- Injectables & sterile fill-finish
- APIs & intermediates
- Nutraceuticals & herbal products
Why Work with Major Healthcare for GMP?
Specialists in emerging markets
Integrated with licensing and facility buildout services
Experience with WHO PQ, EU GMP, MOH audits
Scalable support — from startups to full-scale production units