Our Leadership Team

  • Dr. Fitzgerald brings over 25 years of experience in the pharmaceutical industry, with a strong background in Technical Operations across the product lifecycle. For the past 15+ years, he has served as Head of Quality for organizations holding Clinical (IMPD/IND) and Commercial (MA/NDA/BLA) product authorizations. He is an active contract Responsible Person (RP) ensuring robust regulatory compliance and operational oversight and has hosted multiple Regulatory inspections (HPRA PAI WDA/MIA/MIA IMP, MHLW/PMDA MA) over the past 10+ years with no major findings.

  • Padraig Long has over 17 years of experience in the pharmaceutical industry, specializing in Quality Operations across both small and large molecule programs. He is an experienced Qualified Person (QP) for companies holding Clinical (IMPD/IND) and Commercial (MA/NDA/BLA) authorizations, with responsibility for batch certification and ensuring full compliance with the terms of each company’s Manufacturing and Importation Authorisation (MIA).

Client Feedback

“VQP have exceeded my partner expectations in supporting our requirements to facilitate the release of Drug Product into Europe.  Knowledgeable, experienced, and flexible in their service offering to meet your needs at every step of the process and the team make it easy to collaborate on your project.  Would recommend to anyone who needs support locally or from a remote local such as ours Perth, Australia.”

— Senior Vice President, Quality Operations and Regulatory Affairs, BioCina

"Virtual Quality Partner has been a reliable and knowledgeable partner in supporting our RP and QA operations. Their structured approach to PQS implementation, WDA variation support, and comprehensive quality oversight including training, inspections, and documentation has significantly strengthened our compliance posture. Their collaboration on QTA frameworks and post-transition support has ensured continuity and regulatory alignment. VQP's consistent engagement has added real value to our quality operations."

— Director, Quality Assurance, RxSource

Client FAQ

  • NO, the MAH must provide stability data (ICHQ1) to justify NOT having temperature information on the label (for climate zone I and II).

  • The responsibility for supplier qualification remains with the wholesaler being supplied the product. This activity may be delegated to a 3PL, however, the responsibility remains with the wholesaler. Therefore, the wholesaler should ensure competence of the 3PL, include the activities in an agreement, conduct routine audits of the activity, and ensure that modes of communication are open with the 3PL.

  • The final version EU GDP does not define a specific timeline. Nevertheless, some local adaptions, e.g. Ireland, HPRA specify not greater than 48h storage time limits for logistics providers. You need to demonstrate product integrity has been maintained at all times during storage, transportation, at hubs, cross-docking stations, in transit etc.

  • Yes, you should be ale to demonstrate you can maintain the warehouse temperature all the year round, hence the need for mapping in summer and winter.

  • The Current EU GDP requires manufacturers to have audited and approved all their outsourced activities and have a technical/quality agreement with their service providers. The approach to selection and approval of these facilities should be supported by risk assessment, companies can use shared audits or ‘paper audit’ depending on the complexity of operations and sensitivity of the products involved.