EU Pharmaceutical Market Entry, MIA Importation and QP/RP Services
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 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 holder (M20117/00001), authorised by the Health Products Regulatory Authority in Ireland, permitting the legal importation and release of medicinal products into the EU market. Our MIA services support importation and batch certification, including Qualified Person certification under EU GMP Annex 16 and importation controls aligned with EU GMP Annex 21.
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.
We provide the following professional services, staff augmentation and consulting support to the pharmaceutical and medical devices industry:
- EU Market Entry Support for Non-EU Pharma & Biotech Companies.
- MIA Import and batch certification - through our own MIA (M20117/00001).
- Contract Qualified Person according to Article 48 of Directive 2001/83/EC.
- Contract Responsible Person according to EU GDP guide (2013/C 343/01).
- Contract RP & 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 & embedding.
- Training on key disciplines such as GMDP, Root Cause Analysis, Batch Review, Auditing, Data Integrity and Quality Risk Management.
- Pharmaceutical MIA/ MIA (IMP) and WDA licence application and support.
- QA/PV/Reg support including Bonafides, Deviations, complaints, safety reviews, local PV contact.
Orion GXP Consulting - Our Services
MIA Services
Our MIA authorisation empowers Orion GxP to act as a key partner for pharmaceutical companies seeking compliant and efficient market access across the EU, including the certification of imported medicinal products for release into multiple Member States. Our QPs carry out batch certification according to Directive 2001/83/EC..
Find Out MoreQP and RP/RPi Services
Most of our consultants are QPs and RPs; we have a wide pool available, specialising in all dosage forms and technologies. We have QPs/RPs available across the UK and Ireland, and RPIs in the UK. We also provide these GXP experts for short- or long-term consulting projects.
Find Out MoreQMS Development
& Licensing
We assist 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.
Find Out MoreVendor Audit Services
We have built a strong team of GxP audit professionals with decades of experience in GMDP 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.
Find Out MoreTraining and site support
We work with our clients to ensure that the correct quality culture is embedded in their organisation by training the staff in the core principles of GMP, GDP, or GCP. We offer detailed step-by-step courses in a wide variety of quality, manufacturing, regulatory and engineering disciplines.
Find Out MoreRegulatory, Pharmacovigilance and CMC Support
We assist our clients by providing regulatory, pharmacovigilance, and CMC subject matter experts with decades of experience in dossier preparation, compliance reviews, MA applications, and dealing with EMA and National Competent Authorities. We can also assist with Marketing Authorisation sourcing and MA Transfers and holding.
Find Out MoreLatest News
Meet Our Directors
Our leadership team is made up of experienced consultants who are ready to help, and they have global experience across the healthcare industry.
Charley Maxwell
MANAGING DIRECTOR
Patricia Grimes
DIRECTOR OF OPERATIONS
Lee Maxwell
HR DIRECTOR / BUSINESS ADMIN
Contact Details
IRL Address:
W8 Centre,
Church Lane, Manorhamilton,
County Leitrim,
F91 H2YA
Ireland
UK Address:
Suite 517,
No 49 Piccadilly,
Manchester,
M1 2AP
United Kingdom
Ireland Number
+353 71 98 10101
UK Number
+44 203 475 0375
We are listed in - Enterprise Ireland Directory
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