PNR Pharma was established in 2012 and is comprised of an experienced team of pharmaceutical professionals offering Qualified Person (QP), Quality Assurance (QA) and Project Management solutions for both clinical and commercial products.
Through the integration of supply chain professionals into our team, we strengthen our capacity to streamline processes, improve operational efficiency, and consistently uphold the highest quality standards across the entire pharmaceutical supply chain.
PNR Pharma has an established network of EU and UK Qualified Persons (QPs), who will guide you through your clinical trial process to commercialisation of your product. Our QPs perform GMP audits of all dosage forms, including novel and ATMPs, provide QP declarations to support your regulatory submissions, and will assist you throughout your submission process including CMC reviews of your regulatory documentation. Following manufacture, your allocated QP will perform batch reviews and certify your product for its intended use.
Our QA and Project Management experts work closely with the QPs to ensure there is constant communication between all parties, with our QPs available to be contacted directly and attend conference calls as required by the client.
Through our WDA licences our experienced supply chain team PNR can support with sourcing and procurement of ancillary supplies and comparator products via our approved suppliers to support your clinical study needs.
The company consists of two divisions: PNR Pharma Services Limited, based in the EU (Ireland) and PNR Pharma Consultancy Limited, based in the UK .
In Ireland, the business is licenced by the HPRA for EU importation and QP batch certification of clinical and commercial supplies.
The UK entity is licenced by the MHRA for UK importation and QP batch certification of clinical and commercial supplies from third countries, QP oversight of clinical supplies imported from approved countries and RPI oversight of commercial supplies imported from the EU.
Our services extend to include secondary packaging and labeling, storage and distribution of clinical supplies. With our flexible approach we work to your unique specific requirements so that the pharmaceutical supply chain meets the requisite standards and project milestones.
PNR Pharma also The UK office offers QP consultancy, such as training, GAP analysis and remediation advice, and compliance monitoring.
To run a clinical trial in the EU or UK, the sponsor must have the IMP batches certified by a QP named on an MIA (IMP) licence.
Similarly, commercial products are subject to certification by a QP named on an MIA licence.
PNR Pharma holds the appropriate MIA (IMP) and MIA licences in the EU and UK and offers support to expedite the importation and certification of clinical and commercial products.
HPRA (Irish) licences held (EU access):
MHRA (UK) licences held:
We’d be delighted to have a conversation with you about your requirements.
Email us at enquiries@pnrpharma.com and one of our friendly and experienced team will get back to you, or call us on +44 1495362022.
We will email you to start the conversation
