Importation and Certification for GB Clinical Trials

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Promedix Labs provides importation and batch certification services for Human Investigational Medicinal Products used in clinical trials conducted in Great Britain. Operating under the appropriate Manufacturer’s Authorisation, our Qualified Persons are authorised to certify investigational products across Phase I, Phase II, and Phase III clinical studies.

Promedix Labs is authorised to certify, or import and certify, investigational medicinal products across the following dosage form categories:

• Aseptically manufactured batches including large-volume liquids, lyophilised products, semi-solids, small-volume liquids, solids, and implantable forms.
• Terminally sterilised batches including large-volume liquids, small-volume liquids, semi-solids, solids, and implantable dosage forms.

• Hard and soft capsule formulations.
• Tablets and other solid dosage forms.
• Liquids for internal or external administration.
• Semi-solid dosage forms.
• Transdermal patches.
• Suppositories.
• Pressurised preparations.
• Medicinal gases.
• Chewing gum formulations.
• Impregnated matrices.

• Biotechnology-derived medicinal products.
• Medicinal products of human or animal origin.

In addition, Promedix Labs is authorised to support the importation of intermediates that require further processing prior to use within clinical development programmes.

Importation and certification represent the final quality assurance step within the clinical trial supply chain. This process involves a comprehensive review of manufacturing data, quality documentation, and trial-specific information to enable the Qualified Person to certify each batch with confidence.

Promedix Labs also supports this process through supply chain assessments, including audits, to ensure regulatory compliance is maintained across all stages of manufacture and distribution.

Please contact Promedix Labs if you would like to discuss Great Britain importation and/or batch certification services.