Who we are
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.
PNR Pharma has an established network of EU and UK Qualified Persons (QPs), who will guide you through your clinical trial process and routine supply of commercial product. Our QPs perform site 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.
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.
The company consists of two divisions: PNR Pharma Services Limited, based in the EU (Ireland) and PNR Pharma Consultancy Limited, based in the UK .
The business in Ireland is licenced for importation and QP batch certification of clinical and commercial supplies.
The UK office offers QP consultancy, such as training, GAP analysis and remediation advice; we also provide batch certification of clinical and commercial supplies for the UK where our QPs are named on third party licences.
How we can help you
To run a clinical trial in the EU, 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 and offers support to expedite the importation and certification of clinical and commercial products.
MIA (IMP) – Manufacturers Import Authorisation for Investigational Medicinal Products.
MIA – Manufacturers Import Authorisation, for manufacture and importation of commercial/licensed medicinal products.
WDA (H) – Wholesale Dealers Authorisation (Human), for distribution and wholesale sourcing and supply of medicinal products. Also includes exempt medicines, such as unlicensed medicinal products on a clinical need basis.