Welcome to Orion GXP Consulting
We aim to provide our pharmaceutical clients with expertise, assistance, and an in-depth understanding of the healthcare industry.
Pharmaceutical Consulting Services
Orion GXP Consulting is a GMP and GDP pharmaceutical consulting service serving the UK, Ireland and the EU. We have broad experience in quality and regulatory oversight of the import, manufacture and distribution of pharmaceutical medicinal products. Our expertise includes solid and liquid oral dose, topical creams/ointments, ophthalmic products, aseptic fill-finish, and terminally sterilised products.
We provide the following professional contract services, staff augmentation and consulting services to the healthcare industry:
- Qualified Person according to Article 48 of Directive 2001/83/EC.
- Responsible Person according to EU GDP guide (2013/C 343/01).
- GMP and GDP Mock inspections, site audits and vendor qualification.
- Pharmaceutical QMS development, implementation & embedding.
- Training on key disciplines such as Root Cause Analysis, Batch Review, Auditing, Data Integrity and Quality Risk Management.
- Pharmaceutical MIA and WDA licence application support.
- Due diligence and gap analysis for mergers, acquisitions, and carve-outs.
Our Services
Our TEAM of experienced Consultants are ready to help, and they HAve global experience across the healthcare industry.
QMS Development
If you wish to apply for new licences or expand into new GxP areas you must first ensure that you have a robust Quality Management System (QMS), at Orion gxp we got you covered.
Audits
At Orion Consulting we have built a strong team of GxP audit professionals with decades of experience in GMP audits of global pharmaceutical drug substance and drug product suppliers.
Training
Orion’s consultants 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.
GxP SME Support
Orion Consulting specialises in providing subject matter experts to assist with technical operations in the pharmaceutical industry including; process optimisation, development/scale-up and more.
