Orion GXP Consulting provides good practice consulting services for pharmaceutical, regulatory and medical device companies.
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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:
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.
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.
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.
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.
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.
In the life cycle of any business or department, there are times when a surge of value creation is necessary. Whether it’s securing a critical approval, implementing a new process, or overcoming operational bottlenecks, these moments demand expertise, speed, and precision. This is where a consultant can be the perfect solution—delivering impact without the long-term commitment of hiring permanent specialist resources.
When operating within GxP-regulated environments, maintaining a state of inspection readiness is not just a good practice—it’s a regulatory expectation. Whether applying for a manufacturing and importation authorisation (MIA) or submitting a variation to an existing license, regulatory delays or outright refusals are often the result of poor preparation and lack of genuine operational readiness.
Orion GXP Consulting are proud sponsors of this year’s BioPharmaChem Impact event taking place at the Killashee Hotel in Naas, County Kildare, Ireland. We will also be exhibiting there, so please drop by our stand.
In light of the announcement today that the US will be introducing tariffs on the pharmaceutical industry, I thought we could take a deep dive into the impact and precisely how it is crucial not to stand still. Remaining static in the face of change means falling behind more adaptive competitors. Companies must stay agile, continually reassessing strategies, exploring new markets, and innovating to offset tariff impacts and seize emerging opportunities.
Orion GXP Consulting is delighted to be exhibiting at this year's Making Pharmaceuticals – Co-located with Distributing Pharmaceuticals. Come and visit all our UK colleagues at stand 208 from 29-30 April at Coventry Building Society Arena in Coventry, UK.
