We provide the following professional services, staff augmentation and consulting support to the pharmaceutical and medical devices industry:
- 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
QP Services
Most of our consultants are 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).
Find Out MoreRP and RPi Services
For GDP and distribution, we provide interim Responsible Persons and Responsible Persons 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.
Find Out MoreQMS Development
& Licencing
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 Management and 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
Our team of experienced consultants are ready to help, and they have global experience across the healthcare industry.
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
Nirmal Kaur Tarry
ASSOCIATE DIRECTOR RP/RPi - UK
Patricia Grimes
Associate Director QP/RP - Ireland
Contact Details
IRL Address:
W8 Centre,
Curch Lane, Manorhamilton,
County Leitrim,
F91 H2YA
Ireland
UK Address:
6b Upper Water Street,
Newry,
Co Down,
BT34 1DJ
Northern Ireland
Ireland Number
+353 71 98 10101
UK Number
+44 203 475 0375
Need our help?
Request and appointment or submit a scope today and one of our specialists will review it and get back to you straight away.
