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Your partner in EU GMP Compliance, Automation Solutions and EU Regulatory Services

We offer pharmaceutical manufacturers expert EU GMP consulting, regulatory support, and trigger inspections with European authorities, while also providing advanced automation solutions from IMA Italy to optimize your manufacturing and packaging.

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What we do

Comprehensive Engineering Solution

Our Comprehensive Engineering Solution ensures your facility meets the highest EU GMP standards from the ground up. We specialize in conceptual design that is fully compliant with EU GMP requirements, provide expert review and upgrades to detailed designs, and offer comprehensive qualifications and validations for your facility, utility systems, manufacturing equipment, and computerized systems. With our services, every aspect of your operation is optimized for compliance, efficiency, and technological integrity.

Comprehensive Engineering Solution

QMS Development

Our QMS Development service is designed to ensure your quality management system is both effective and fully compliant with cGMP guidelines. Our team of experts collaborates closely with your team to develop and implement tailored processes, policies, and procedures that meet the specific needs of your operation. We also offer customized cGMP training programs to equip your staff with the knowledge and skills necessary to maintain compliance and uphold the highest standards of quality in your organization.

QMS Development

GAP Analysis & Pre-inspection EU QP Audit

Our GAP Analysis and EU QP Pre-inspection Audit service is designed to ensure your facility is fully prepared for the final EU GMP Inspection. We start by thoroughly auditing your production sites to identify any gaps in compliance. The EU QP Pre-Inspection Audit, followed by a detailed Corrective and Preventive Action (CAPA) plan, significantly enhances your facility’s chances of passing the final inspection. With our expert guidance, you can be confident that your facility is ready to meet the stringent requirements of EU cGMP standards.

GAP Analysis & Pre-inspection EU QP Audit

Triggering of EU GMP Inspection

We streamline the inspection scheduling process by acting as your liaison with regulatory authorities in Europe, securing a slot for your facility’s EU GMP inspection. During the inspection itself, we stand by to assist your team as needed. Our expertise helps you navigate this critical stage with clarity and confidence, ultimately working towards acquiring your EU GMP Certificate.

Triggering of EU GMP Inspection

EU Regulatory Services

Our EU Regulatory Services are tailored to guide your product through the regulatory landscape with strategic advice and hands-on support, starting from compiling a dossier to achieving market approval and beyond. We work closely with you to navigate the complexities of EU regulations, ensuring your product meets all necessary standards and remains compliant throughout its lifecycle. With our support, you can confidently manage the regulatory requirements and achieve successful outcomes in the European market.

EU Regulatory Services

Our Process

01
phase 1

Feasibility Study

In the Feasibility Study phase, we conduct a thorough assessment of your project’s potential. This involves evaluating the necessary resources, analyzing the market and competitors, and assessing the capabilities of your team. We also perform a comprehensive risk evaluation to ensure that all potential challenges are identified and addressed.

02
phase 1

Conceptual Design

Our Conceptual Design phase ensures your facility’s compliance with the selected regulatory framework. Tailored to your products and processes, this design forms the foundation for an EU GMP compliant facility, aligning with regulatory requirements to support efficient and compliant operations.

03
phase 1

Establishing and Implementing of Quality Systems

We develop a tailored Quality Management System (QMS) and implement it within your facility to ensure the sustainable quality and efficacy of your pharmaceutical products. This customized QMS is designed to maintain consistent compliance with regulatory standards, fostering long-term reliability and excellence in your manufacturing processes.

04
phase 2

Technological Engineering Plan

We support your detailed designers to ensure they follow the conceptual design and that the detailed design is fully compliant with GMP standards. Our engineering team supervises your construction contractors to guarantee that every aspect of the design is implemented according to GMP requirements, ensuring your facility meets the highest standards of compliance and operational integrity.

05
phase 2

Qualifications of utility systems and equipment

We actively participate in the integrated qualifications of facility, utility systems and equipment, working alongside your vendors and your team. We review all qualification documents provided by the vendors to ensure that all documents meet EU GMP standards.

06
phase 2

Validation processes

We provide comprehensive support during the process validation, cleaning validation, and analytical methods validation. Our team offers on-site support to ensure that all validation activities are thoroughly executed and compliant with GMP standards.

07
phase 3

Triggering of Inspection

We act as your voice in communication with EU authorities, securing an inspection slot for your facility.

08
phase 3

EU GMP Audit

Our Qualified Person (QP) conducts a thorough mock inspection to assess your facility's compliance with EU GMP standards. Following the audit, we assist in implementing a Corrective and Preventive Action (CAPA) plan. This step is mandatory in our process and ensures that your team is well-prepared and confident, increasing the likelihood of a smooth and successful EU GMP inspection.

09
phase 3

Certification

Following the EU GMP inspection, we act as your representative in communication with the authorities, guiding the process of post-inspection CAPA and facilitating the publication of your certificate on the EudraGMP website. Our involvement helps to streamline the final steps, securing your certification and confirming your compliance with EU standards.

10
phase 3

Regulatory Services

We prepare a comprehensive regulatory strategy tailored to your product, review, upgrade or compile your eCTD, and manage all submission processes. Our team communicates directly with the authorities on your behalf, handling each step until your product receives marketing authorization. Additionally, we provide pharmacovigilance services and batch release site.

Our Clients in Vietnam

Hai Duong Pharmaceutical Medical Material JSC

Hai Duong Pharmaceutical Medical Material JSC

We completed their OSD Non-beta Lactam Green Field Project, certified in April 2022, and provided Turnkey Compliance Consulting and supplied IMA sterile dry powder in vials for injection line, along with a full OSD line equipped with packaging solutions from IMA for their Cephalosporin Green Field Project, which is ongoing.

Why EZGMP?

European expertise
EZ GMP
01

Over a Century of Combined Expertise in the Pharmaceutical Industry

Our team’s extensive experience, spanning over a century, gives us unparalleled insight and understanding of the industry, enabling us to provide tailored, effective solutions that are formed by decades of proven success.

02

Global Expertise at Your Doorstep

Our presence in Vietnam brings world-class European expertise directly to your doorstep, ensuring you receive the highest standards of service and compliance support right where you need it.

03

We are a team of European EU GMP Experts

Our experts have extensive experience working in European manufacturing facilities, where EU GMP compliance is an integral part of their daily operations.

Schedule Your Consultation with an Expert

Whether you’re exploring EU GMP, seeking Regulatory Consulting, or looking into Automation Solutions, our experts are ready to assist you.

Marsileza Jumarova
in

Marsileza Jumarova

Chairwoman & Senior EU GMP Consultant

Marsileza is your go-to expert for all matters related to EU GMP Consulting and Regulatory Affairs. Schedule a consultation with her for comprehensive guidance on navigating EU compliance.

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Petr Jumar
in

Petr Jumar

Automated Solutions Accounts Manager

For budgetary quotations or spare parts inquiries, Petr is the expert to connect with. Reach out to him for tailored support and solutions for your automation needs.

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Ho Cong Hau
in

Ho Cong Hau

Sales and business development manager

Hau supports pharmaceutical manufacturers in finding the right IMA Italy solutions and coordinates projects, quotations, and communication with the appropriate IMA teams.

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Contact us

Let's
Get In Touch!

If you’re looking to get in touch for a general inquiry or you are an equipment supplier interested in partnering with us in Vietnam, we’re eager to hear from you.

info@ezgmp.co
+84 934 583 066

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