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Expanding your pharma business into the European market requires compliance with the Pharma EU-GMP standards and EU drug registration requirements. These certifications not only grant access to Europe but also facilitate fast-track market entry into 75+ countries worldwide, including Latin America, the Middle East, Asia, Australia, and Canada.
Understanding EU-GMP Certificate: The Gateway to European Markets
Successfully obtaining Pharma EU-GMP certificate and Drug Registration requires expertise in EU regulations, compliance strategies, and efficient communication with European authorities. A CPC GMP Pre-Audit helps identifying bottlenecks, regulatory gaps, and prepares your facility for EU inspectors’ questions. Once the Pharma EU-GMP is certified, companies must navigate drug registration, ensuring dossiers meet EU/EMA guidelines for Rx, OTC, and Herbal drugs.
Figure 1: European & International market entry pathway with EU-GMP
Step by Step Pre-Audit Process for EU-GMP Certification
Figure 2: GMP Pre-Audit regarding EU-GMP and timing
CPC Pre-Audit regarding EU-GMP Process – I
Step A – List of Requirements/ Expert Intro Meeting
- CPC aligns with your local team to prepare a Pre-Audit process.
- We will set-up and expert call and explain the important topics regarding Pharma EU GMP requirements, and those topics EU government inspectors will check with priority after the Pre-Audit.
Step B – Exchange of GMP Documents
- CPC provides transparency on necessary GMP documents and their legal status.
- We clarify which documents need apostille and legalization for the official EU-GMP inspection.
- CPC assists in preparing official regulatory documentation where applicable.
Step C – Pre-Audit Preparation & Document Review
- CPC conducts a comprehensive review of the client’s GMP documents beforehand.
- CPC will share a local Pre-Audit Plan (similar to official EU GMP government inspection).
- We will analyse specific GMP documents such as SMF, QC and QA topics regrading EU GMP rules.
CPC Pre-Audit regarding EU-GMP Process – II
Step D – Pre-Audit (Remote or On-Site at Your Factory)
- CPC experts conduct the Local factory GMP Pre-audit at your local factory line.
- The Pre-Audit will be conducted in the same structure and details like an EU government Audit – so it is a good training + test for your factory & regulatory team.
- Our CPC experts will need approx. 3-5 days remote by video or in person at your factory.
- We will present the findings of the Pre-Audit at each day in the evening.
- We will present the first Management Summary on the last day of the Pre-audit at your plant.
Step E – Management Report & Next Steps
- CPC will share the EU GMP requirements, and the topics government inspectors will check with priority after the Pre-Audit.
- CPC summarizes the Key findings in a Management Report about 4-5 weeks after the Pre-Audit.
- With our CPC Pre-Audit you have 90% of the EU-GMP preparation done.
Optional Support that CPC offers:
- On request we can support you to set-up the CAPA Plan
- CPC will support you to close the GAPs identified and conduct training
of your team before the official EU-GMP government inspection - CPC can conduct a GAP analysis of your product registration files
CPC added value services regarding Regulatory & GMP
- Importing your products to Europe
- Supporting you to win EU Pharma product tenders
- Warehouse services (EU GMP standard)
- Hosting your MA in Europe + doing pharmacovigilance
- Releasing your products in the EU markets
- Support you to Systematically identify a Local
Partner Company in key EU countries - We conduct all kind of Drug, MD, FS registration in the EU
At CPC, we specialize in guiding pharma companies to successfully obtain Pharma EU-GMP certification and Drug Registration. With proven expertise, a 99% success rate in the EU GMP inspection, and a strong track record in securing Marketing Authorizations for Rx, OTC, and Herbal drugs, we simplify the complex EU regulatory process. Expanding into Europe can be complex, but with our expert guidance, your company can achieve compliance, unlock new international market opportunities and thrive in the EU market.
Chameleon Pharma Consulting Group (CPC) has over 20 years of experience in supporting Pharma, OTC, Medical Devices, Phyto, and Aesthetic Medicine companies. Having established own offices & local hubs across Latin America, Europe, Asia, the US/Canada, the Middle East, and the CEE/CIS regions is another advantage of CPC. With this local network and expertise gained from 300+ international projects and a team of 25 experts we offer our clients:
- Business Development, M&A, and Due Diligence
- Market Entry & Expansion: Systematic product and country analysis, market reports
- Strategic Partnering: Identifying local partners, acquisitions, or setting up own offices
- Regulatory & Registration: for drugs, MD, Derma, Aesthetic Medicine, etc.
- Market Authorization & Compliance: Holding MAs, conducting pharmacovigilance
- Quality & Certification: GMP certification, pre-GMP audits
Contact us today for your individual request at service@chameleon-pharma.com!
