PNR Pharma is a reputable pharmaceutical brand that was founded in 2012. Our team consists of highly experienced professionals in the field who specialize in providing a range of services, including Qualified Person (QP) support, Quality Assurance (QA), and Project Management solutions for both clinical and commercial products. With an established network of EU and UK Qualified Persons (QPs), PNR Pharma ensures that your clinical trial process and routine supply of commercial products are guided by experts.

Our QPs conduct site audits for all dosage forms, including novel and Advanced Therapy Medicinal Products (ATMPs). They also provide QP declarations to support your regulatory submissions and offer assistance throughout the submission process, including CMC (Chemistry, Manufacturing, and Controls) reviews of your regulatory documentation. Our QA and Project Management experts work closely with the QPs, ensuring seamless communication between all parties.

Our QPs are readily available for direct contact and can attend conference calls as needed. PNR Pharma consists of two divisions: PNR Pharma Services Limited in the EU (Ireland) and PNR Pharma Consultancy Limited in the UK. Our Irish facility is licensed for importation and QP batch certification of clinical and commercial supplies, while our UK office offers QP consultancy services, such as training, GAP analysis, and remediation advice.

We also provide batch certification for the UK market, where our QPs are named on third-party licenses. To facilitate clinical trials in the EU, it is essential to have the Investigational Medicinal Product (IMP) batches certified by a QP named on a Manufacturers Import Authorization (MIA) license. Similarly, commercial products must be certified by a QP named on an MIA license.

PNR Pharma holds the necessary MIA (IMP) and MIA licenses and offers support in expediting the importation and certification process for clinical and commercial products. Our licenses include: - MIA (IMP) for importation of Investigational Medicinal Products. - MIA for manufacture and importation of commercial/licensed medicinal products.

- WDA (H) for distribution and wholesale sourcing and supply of medicinal products. This includes exempt medicines, such as unlicensed medicinal products based on clinical needs. We would be delighted to discuss your specific requirements.

Feel free to contact us via email at enquiries@pnrpharma. com or by calling +44 1495362022. Our friendly and experienced team will promptly assist you.

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