Contract Qualified Person (QP) Services

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Promedix Labs provides contract Qualified Person services delivered by professionals eligible under applicable EU and UK regulatory frameworks. Our QPs support Marketing Authorisations and other licensed pharmaceutical activities in Great Britain, covering a broad range of medicinal product types and dosage forms.

Our experience spans the certification and oversight of sterile medicinal products, including aseptically manufactured and terminally sterilised dosage forms such as large-volume liquids, small-volume liquids, lyophilised products, semi-solids, solids, and implantable products.

We also provide QP support for a wide range of non-sterile medicinal products, including hard and soft capsules, tablets (including rapid-dissolve formats), liquids for internal and external use, semi-solid preparations, suppositories, lozenges, chewing gum formulations, impregnated matrices, nasal sprays, transdermal patches, medicinal gases, and other solid dosage forms. Our scope additionally includes pressurised preparations such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs).

Promedix Labs’ QPs also support biological medicinal products, including biotechnology-derived products and medicinal products of human or animal origin. Where required, we are able to provide QP services for veterinary medicinal products in line with applicable regulatory requirements.

Our contract QP services are designed to be flexible and responsive, supporting both short-term and long-term requirements while ensuring consistent regulatory compliance and product quality.

Please contact Promedix Labs if you would like to discuss our contract Qualified Person services or specific product requirements.