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Are You Ready for EU GMP Annex 1?

  Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971, providing specific guidance on the minimum controls required to ensure sterility of medicinal products during manufacture. In…

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Is your vendor management programme compliant?

Is your vendor management programme compliant? PNR Pharma has the expertise to conduct API and finished product audits for all product types, including sterile and ATMPs to determine compliance with GB…

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Time is running out! Annex 1 is almost here!

Time is running out! Are you ready for the new PICs/EU GMP Annex 1, the Manufacture of Sterile Medicinal Products, to comply with the requirements of Eudralex Volume 4 and…

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PNR approved for the MIA (IMP) QP oversight license

PNR Pharma currently has IMP, MIA and WDA licences authorised by the HPRA. Allowing the QP certification of both clinical and commercial supplies within the EU. As part of the…

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Is your manufacturer GMP compliant?

Is your manufacturer in compliance with current GMP? PNR can assist with remediation of deficiencies identified in an audit and bridge gaps in your site’s Quality Management System. We can…

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Prevent hold-ups and frustration with clinical supplies

When planning clinical project timelines, the certification of batches by the QP can be a rate limiting step causing hold-ups and frustration within the clinical supplies team. Being able to interact with and…

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Season’s greetings from PNR!

Season’s Greetings from the PNR Pharma team. Wishing you all the best for the holidays and looking forward to further supporting our clients through 2023

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Kostas at CPHI Frankfurt!

PNR colleague Kostas visiting partners at CPHI Frankfurt.

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A must see post from the HPRA

Post from the HPRA: We have published recordings from our recent #IVDR webinar for manufacturers, importers, distributors, health institutions, authorised representatives and performance study sponsors working to implement the new Regulation. Five…

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