Orion GXP Consulting
Our Services
Our team of experienced consultants are ready to help, and they have global experience across the healthcare industry.
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, PV 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 MoreWe can assist with a variety of services from Regulatory and PV support, QMS development, vendor auditing, Technical GXP support and training. Our consultants are familiar with industry regulations relating to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), MDR/ISO13485 (medical device), or other regulatory standards to be applied. We have a panel of expert technical professionals experienced in authoring QMS procedures. These are then expertly written in conjunction with the associated GxP regulations and utilising industry best practices. This is just one of the many services our expert consultants can offer.
Orion Consulting can assist with all manner of validation projects, from facility commissioning and temperature mapping to systems and Computer Systems Validation (CSV) qualification. We would be happy to discuss your individual needs with one of our experienced Validation Consultants.
Please contact us today to discuss your needs, and we will arrange a no-obligation one to one consultation.