Orion GXP Consulting is a leading provider of good manufacturing practice (GMP) and good distribution practice (GDP) consulting services for the pharmaceutical, regulatory and medical device industries in the UK, Ireland, and across the European Union.
We have extensive experience in quality and regulatory oversight of the import, manufacture, and distribution of pharmaceutical medicinal products in a wide range of dosage forms. Our growing team of expert consultants represents the very best of the industry and provides all our clients with an unrivalled level of support.
Our team of experienced consultants are ready to help and have global experience across the healthcare industry. We provide the following professional services, staff augmentation and consulting support to the pharmaceutical and medical device industries:
- Contract Qualified Person (QP) according to Article 48 of Directive 2001/83/EC
- Contract Responsible Person (RP) according to EU GDP guide (2013/C 343/01)
- Contract RP and Responsible Person Import (RPi) according to the UK Human Medicines Regulation 2012
- Quality, regulatory and pharmacovigilance support
- Due diligence and gap analysis for mergers, acquisitions and carve-outs
- Vendor management, including GMP, GDP and GVP audits
- Quality management system (QMS) development, implementation and embedding
- Training on key disciplines such as GMDP, root cause analysis, batch review, auditing, data integrity, and quality risk management
- Pharmaceutical MIA, IMP and WDA licence application and support
- QA/PV/Reg support, including bona fides, deviations, complaints, safety reviews, and local PV contact
Qualified and responsible person services
Most of Orion GXP Consulting’s consultants are qualified practitioners (QPs) and we have a wide pool available specialising in all dosage forms and technologies. Our QPs are ready to be listed on client MIA/MIA-IMPs and carry out batch release according to Directive 2001/83/EC (human), Regulation (EU) No 536/2014 (clinical) and Regulation (EU) 2019/6 (veterinary).
We provide interim Responsible Persons (RPs) for GDP and distribution, as well as RPs for import services to the pharmaceutical industry. We have RPs available across the UK and Ireland and RPIs in the UK, and we also provide these GDP experts for short-term or long-term consulting projects.
MIA import and batch release services
Orion GXP Consulting offers end-to-end support for overseas clients, including sourcing marketing authorisations (MAs) and finding CMOs. We also provide contract import and QP release via our manufacturing and import authorisation (MIA) service. This service is available in the UK and throughout the EU, regardless of where the material physically enters the union.
Services for QMS development and licensing
Orion GXP Consulting assists clients in expanding their range of products and launching products in new territories by developing the required licensing and QMS requirements. This includes writing new procedures, identifying additional resources, assisting with the necessary licence applications, and completing any remediation work needed.
An effective QMS will consist of all the business processes, personnel responsibilities and standards, including manuals, policies and procedures, that are required to guarantee that regulated processes are carried out in a controlled manner and ensure the manufacture of high-quality, safe and effective products.
We work with our clients to develop a bespoke set of QMS documentation that is written with all your company’s proposed facilities, products and manufacturing/business processes in mind. We then follow up to ensure that the written processes are trained out and can be effectively implemented and bedded in at your manufacturing and distribution facilities.
Regulatory, pharmacovigilance and CMC support
Orion GXP Consulting assists our clients by providing regulatory, pharmacovigilance, and chemistry, manufacturing and controls (CMC) subject matter experts with decades of experience in dossier preparation, compliance reviews, MA applications, and dealing with the European Medicines Agency (EMA) and National Competent Authorities. We can also assist with MA sourcing, transfers and holding.
Audit and vendor management services
Orion GXP Consulting has built a strong team of good practice (GxP) audit professionals with decades of experience in GMP and GDP audits of global pharmaceutical drug substances, drug product suppliers, and wholesalers, including third-party logistics partners. We can also assist with mock facility inspections and vendor qualification using a mix of on-site, survey, and remote inspection capabilities.