Your Facility,
Certified for the World
Pharmaco Global’s in-house Regulatory Services team guides pharmaceutical manufacturers through the complete EU GMP certification journey — from gap analysis to approved certificate — so you can export to regulated markets with confidence.
Regulatory Frameworks We Cover
Our 7-Step Certification Process
Gap Analysis
Our in-house regulatory team assesses your current facility against target regulatory standards, identifying deficiencies in infrastructure, documentation, and quality systems. You receive a clear, prioritised remediation plan so you know exactly what needs to be fixed and in what order.
Documentation & Dossier Preparation
We prepare your complete regulatory submission package: eCTD dossier (Electronic Common Technical Document), Site Master File (SMF), Quality Management System (QMS) documentation, Standard Operating Procedures (SOPs), and validation protocols and reports.
Pre-Inspection Preparation
Before any inspector visits, we conduct rigorous internal readiness checks: mock GMP audits simulating actual inspector behaviour, CAPA (Corrective and Preventive Action) preparation, staff briefing and audit-response training, and full facility walkthrough and documentation alignment.
Submission to Qualified Person (QP)
Completed documentation is submitted to our established network of Qualified Personnel (QPs) in Europe. The QP evaluates the dossier on behalf of your facility and prepares it for inspector review. Our established QP relationships mean faster turnaround and fewer back-and-forth cycles.
EU Inspector Review
The QP presents documentation to the appointed EU regulatory inspector. All inspector queries are managed through our team, ensuring timely, accurate, and professionally drafted responses that protect your submission.
Physical Facility Inspection
If documentation is approved, the inspector visits your facility for a physical GMP inspection. Our regulatory team accompanies throughout, managing observations in real time and ensuring your team is confident and well-prepared.
Certification & Market Access
Minor observations are corrected and responded to with CAPA documentation. Upon approval, your facility receives EU GMP certification, unlocking export to 44+ regulated markets across Europe and beyond.
1. Gap Analysis
Our in-house regulatory team assesses your current facility against target regulatory standards — identifying deficiencies in infrastructure, documentation, and quality systems. You receive a clear, prioritised remediation plan so you know exactly what needs to be fixed and in what order.
2. Documentation & Dossier Preparation
We prepare your complete regulatory submission package: eCTD dossier (Electronic Common Technical Document), Site Master File (SMF), Quality Management System (QMS) documentation, Standard Operating Procedures (SOPs), and validation protocols and reports.
3. Pre-Inspection Preparation
Before any inspector visits, we conduct rigorous internal readiness checks: mock GMP audits simulating actual inspector behaviour, CAPA (Corrective and Preventive Action) preparation, staff briefing and audit-response training, and full facility walkthrough and documentation alignment.
4. Submission to Qualified Person (QP)
Completed documentation is submitted to our established network of Qualified Personnel (QPs) in Europe. The QP evaluates the dossier on behalf of your facility and prepares it for inspector review. Our established QP relationships mean faster turnaround and fewer back-and-forth cycles.
5. EU Inspector Review
The QP presents documentation to the appointed EU regulatory inspector. All inspector queries are managed through our team, ensuring timely, accurate, and professionally drafted responses that protect your submission.
6. Physical Facility Inspection
If documentation is approved, the inspector visits your facility for a physical GMP inspection. Our regulatory team accompanies throughout, managing observations in real time and ensuring your team is confident and well-prepared.
7. Certification & Market Access
Minor observations are corrected and responded to with CAPA documentation. Upon approval, your facility receives EU GMP certification — unlocking export to 44+ regulated markets across Europe and beyond.
Markets You Can Access After Certification
A single EU GMP certificate does not just open one door. It positions your facility as a world-class GMP manufacturer — capable of supplying to global tenders, multinational partners, and regulated distributors worldwide.
EU GMP certification enables your facility to supply to regulated markets including:
- European Union — all 27 member states
- United Kingdom — via MHRA recognition
- WHO prequalification markets across Africa, Asia, and Latin America
- GCC countries and regulated MENA markets
- Australia, Canada, and other markets with EU GMP recognition agreements
FAQ's
EU GMP certification confirms that a pharmaceutical manufacturer’s facility, processes, and quality systems comply with EudraLex Volume 4 — the European Union’s Good Manufacturing Practice guidelines. It is issued by a National Competent Authority following a physical facility inspection and is mandatory for exporting finished pharmaceuticals or APIs to any of the 27 EU member states.
EU GMP certification follows seven stages: regulatory gap analysis, documentation and dossier preparation — including Site Master File, QMS, and SOPs — mock GMP audit, submission to a Qualified Person (QP) in Europe, EU inspector review, physical facility inspection, and CAPA response leading to certificate issuance. The process typically takes 12–24 months from initial gap analysis.
EU GMP certification typically takes 12–24 months from initial gap analysis to certificate issuance, depending on facility readiness, documentation maturity, and inspector scheduling. Facilities with major infrastructure gaps take longer. EU GMP certificates are valid for three years from the date of inspection, after which a new inspection and re-certification are required.
WHO GMP certification enables export to developing markets and UN procurement channels. EU GMP certification — granted after a physical inspection by a European National Competent Authority — is required for supplying all 27 EU member states and is recognised by 44+ additional regulated markets including the UK, GCC, Australia, and Canada. EU GMP is the stricter and more commercially valuable standard.
EU GMP certification unlocks export to all 27 EU member states, the UK via MHRA recognition, WHO prequalification markets across Africa, Asia, and Latin America, GCC and regulated MENA markets, and countries with EU GMP mutual recognition agreements including Australia, Canada, Japan, and Switzerland — making it the single most commercially valuable GMP certificate a manufacturer can obtain.
A GMP gap analysis compares a pharmaceutical manufacturer’s existing facility, documentation, and quality systems against the target regulatory standard — EU GMP, WHO GMP, or USFDA. It identifies specific deficiencies in infrastructure, SOPs, validation records, and quality systems, and produces a prioritised remediation plan so manufacturers know exactly what must be corrected before inspection.
A Qualified Person (QP) is a legally designated individual required under EU pharmaceutical legislation who reviews and certifies each batch of medicinal product before release to the EU market. In the certification process, the QP evaluates the manufacturer’s regulatory dossier, liaises with the appointed EU inspector, and confirms the facility meets EU GMP standards on behalf of the marketing authorisation holder.
EU GMP certification requires a Site Master File (SMF) describing the facility, manufacturing activities, and quality systems; an eCTD-format regulatory dossier; Standard Operating Procedures (SOPs); validation protocols and reports covering equipment, utilities, cleaning, and processes; CAPA records; and batch manufacturing records — all prepared to EudraLex Volume 4 format before submission to the Qualified Person and EU inspector.
