EU Clinical Trial Importation & Batch Release

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Promedix Labs supports the importation and certification of Human Investigational Medicinal Products for clinical trials conducted within the European Union. We operate under the appropriate regulatory authorisations, enabling our Qualified Persons to perform batch certification in line with EU regulatory requirements.

Our scope of certification covers a broad range of dosage forms, including sterile, non-sterile, and advanced biological products used in clinical development programmes.

• Sterile medicinal products.
• Non-sterile medicinal products.
• Biological and biotechnology-derived products.
• Products of human or animal origin.

• Sterile products, including aseptically prepared and terminally sterilised forms.
• Non-sterile medicinal products.
• Biological and biotechnology products.
• Products derived from human or animal sources.

Certification and importation represent the final assurance stage within the clinical trial supply process. This involves a comprehensive review of manufacturing data, quality documentation, and trial-specific information to ensure the Qualified Person can certify each batch with confidence.

Promedix Labs also provides full supply chain assessment services, including audits, to support informed certification decisions and maintain regulatory compliance throughout the product lifecycle.

If you would like to discuss EU clinical trial importation or batch certification services, please contact our team for further information.