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Basic Info

Orion GXP Consulting supports pharmaceutical and life-science companies in successfully expanding operations in Europe and maintaining compliant, inspection-ready operations across the UK and EU.

We specialise in helping organisations establish and scale within the European market through expert Quality and Regulatory support for new marketing authorisation applications, EU market entry, and ongoing GMP and GDP compliance. Our team provides experienced Qualified Persons (QP), Responsible Persons (RP), and specialist subject-matter experts (SMEs) to address short-term capability gaps, lead remediation programmes, and support critical quality and regulatory projects.

Orion GXP Consulting is a Manufacturing and Importation Authorisation (MIA) holder (M20117/00001), authorised by the Healthcare Products Regulatory Authority in Ireland. We have extensive expertise in quality and regulatory oversight of the importation, manufacture, and distribution of medicinal products, we partner with companies across the product lifecycle, from initial EU entry and licensing through to commercial supply and distribution.

Why work with us

Orion GXP Consulting was established to provide expert consultants representing the industry's finest talent and to deliver an unrivalled level of support to their clients. The Orion team often covers short-term expansion, remediation projects, or staff augmentation, where additional interim support is required to cover gaps within organisations or leave. Orion strongly believes in delivering excellence in the pharmaceutical and medical device consulting landscape and is steadfastly committed to compliance with best practices in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

Clients (3)

RxSource

RxSource provides global clinical trial sourcing, packaging and labelling, and storage and distribution services for the pharmaceutical and biotech industry. Our passion drives us to be the ... read more

FreightSpeed

FreightSpeed: Ireland's top pharmaceutical logistics provider with 30+ years of experience in temperature-controlled warehousing and distribution for leading pharmaceutical companies. read more

Bausch + Lomb

Bausch + Lomb is one of the world's largest suppliers of contact lenses, lens care products, prescription pharmaceuticals, intraocular lenses and other eye surgery products. Our core busines... read more

Brochure

Video

Company focus

Services

Life Sciences & Health Tech
Healthcare & Pharma Services

Industries

Pharmaceutical & Biopharmaceutical
Pharma-Life Science Lab

Projects or Case studies (1)

Eyecare Brand, Importing and Virtual Wholesaling in Dublin

September 2021 -

This client was the first client of Orion GXP Consulting, dating back to late 2021. Our Managing Director made a long-term commitment to steer them through the difficulties of a restructuring and the loss of their Head of Quality and QP/RP in the same month. We continued to work with them through 2022 as they expanded, ensuring that the remaining staff were trained, mentored, and developed over time into the QP & RP roles. Orion remained on the sidelines in a DRP and backup QP capacity, and when further exits occurred in late 2024, we were able to quickly step in and ensure their products could continue to be imported, released and distributed throughout the EU. On many occasions, this company has acknowledged the benefit of this relationship, and we continue to support them with RP and backup QP resources.

Contacts

Charley Maxwell Avatar

Charley Maxwell