Inthera has been a trusted pharmaceutical service provider since 1991. EU GMP (European Union Good Manufacturing Practice) is a set of quality assurance guidelines and standards that ensure the consistent production and control of medicinal products within the European Union.

To obtain EU GMP certification, pharmaceutical companies must demonstrate compliance with these rigorous standards, covering areas such as personnel, premises, equipment, documentation, production, quality control, and distribution. 

This involves implementing comprehensive quality management systems, conducting regular audits, adhering to strict manufacturing processes, and maintaining detailed documentation to prove compliance with EU pharmaceutical manufacturing requirements. Once a company's manufacturing facilities meet all EU GMP criteria, they can apply for certification through ANY relevant national PHARMACEUTICAL AGENCY IN THE EU.

What Inthera offers


EU GMP preparation

Our experts specialize in preparing non-EU pharmaceutical companies for EU GMP certification. We provide comprehensive guidance on regulatory requirements, documentation, and best practices to ensure your facilities meet EU standards.

Mock virtual inspection

To help you prepare for the rigors of an actual EU GMP inspection, we conduct mock virtual inspections. This invaluable practice enables you to identify and address potential compliance issues before the official inspection takes place, minimizing the risk of non-compliance.

On-site audit

Our experienced auditors conduct thorough on-site audits of your manufacturing facilities. With meticulous attention to detail, we assess your operations against EU GMP guidelines, providing actionable insights and recommendations for improvement.

SOP review

Standard Operating Procedures (SOPs) are the backbone of EU GMP compliance. Our team reviews your existing SOPs, ensuring they align with EU manufacturing equirements and industry best practices. We offer guidance on SOP development and optimization to enhance your compliance efforts.

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Why choose us?

We offer unparalleled expertise in guiding non-EU pharmaceutical companies through the complex process of obtaining certification. Our tailored solutions are designed to address your specific challenges and ensure seamless alignment with EU pharmaceutical regulatory standards.

With our commitment to excellence and global reach, you can trust us to help you achieve and maintain compliance with confidence.

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