Qualified Person (QP) Services including Batch Release 

As a Manufacturing/Importers Authorisation (MIA) and MIA-IMP (Investigational Medicinal Products) holder in the EU, JensonR+ offers an EU Qualified Person (QP) certification solution for both commercial and clinical products and we can support you with your EU QP Certification and batch release requirements.

Our HPRA authorised team in Ireland cover a range of dosage forms including biologics, oral solid dosages (OSDs), liquids and inhalation products and we have supported clinical trials for non-EU sponsors. 

In addition, we have established relationships with authorised physical sites of importation and EU QC test sites to support a complete solution for GMP batch testing and batch release. We can provide support in the following areas, either directly or via our network:  

Qualified Person
  • Batch release of IMP and commercial batches  

  • Supporting Quality Management System (QMS) implementation and improvement 

  • Regulatory inspection support including mock inspections, training, execution and responding to regulatory findings

  • Clinical trial support

  • Early Access Programme (EAP)/Compassionate Use Programme (CUP) support

  • Warehousing, sampling, EU depot and shipment (via logistic partners)

  • Issuing Qualified Person declaration for IMPs and marketed products

  • Auditing manufacturing supply chain

  • Managing quality agreements

  • Maintaining Product Specification File (PSF) in line with the clinical trial regulation requirements

  • Project management support

JensonR+ will manage the EU batch release and certification by a Qualified Person, and in addition, can help you manage your EU requirements regarding importation and retesting.    

We will conduct GMP, GCP, GVP and GLP auditing as appropriate for drug substance manufacturers, drug product manufacturers, Marketing Authorisation Holders (MAHs), laboratories, warehouses and Clinical Research Organisations (CROs).  Our team of highly experienced QPs all have proven track records including delivering on Good Manufacturing Practice (GMP) remediation projects and hosting successful regulatory inspections. 

We can assist in securing Manufacturing/Importation Authorisations (MIA) and Wholesale Distribution Authorisations (WDA), including interacting with the relevant competent authority i.e. Medicines and Healthcare Products Regulatory Agency (MHRA) or Health Products Regulatory Authority (HPRA), MHRA portal set-up, application preparations, submissions, inspection support and close-outs. We have experience in supporting global clients to obtain authorisations from relevant competent authorities.  

We offer QP services on a temporary or ongoing basis. This includes naming QPs on an existing MIA or MIA-IMP, training in-house personnel to become QPs and/or support during the QP recruitment selection process. 

Our Technical team can review and implement quality management systems and conduct risk management assessments, and we can even act as your quality department for companies needing to outsource technical activities. We have experience in complying with the European Commission Falsified Medicines Directive and can support you with product serialisation.  

Get in touch with us to find out more