EU QUALIFIED PERSON SERVICES

RenaClinical was founded by two QPs who remain active in the company.  Our QPs have a wide range of knowledge & experience to provide expert regulatory & CMC advice to clients when planning clinical trials.  The QPs can provide specialist advice on a wide range of dosage forms & practical manufacturing advice for small and large scale production.  Both QPs can perform UK & EU batch release for clinical and commercial drug products.
 

The RenaClinical QPs were instrumental in the development & implementation of a De-centralised Manufacturing Process for a time-critical ATMP IMP that was the first of its type to receive MHRA CTA approval. 

QP Auditing

All RenaClinical QPs are IRCA trained lead auditors with extensive global experience in auditing the following product types & areas:

  • Active substances (API)

  • Biotechnology Active Substances & Drug Product 

  • Sterile & Non-sterile Drug Products

  • QC Laboratories including Data Integrity Audits

  • ATMP & Radiopharmaceutical Drug Products

  • Packaging & labelling sites

  • Warehousing & Storage sites

RenaClinical also has several regional 3rd party approved auditors to provide additional global auditing capacity

QP Consultancy & Training Services

Our QPs are on hand to provide expert consultancy advice to all types of clients.  The QPs are always happy to discuss your clinical or commercial requirements via FREE QP consultations.

QP 3rd Country GMP Declarations 

QP Batch certification and release (UK & EU)

  • To mitigate the effect of Brexit RenaClinical has setup an Irish QP batch release site

  • The two sites are fully integrated to enable a smooth and hassle free solution for EU and UK IMP supply chains

Get in touch for more information or your FREE QP consultation 

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