Orion GXP Consulting Services
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 Oriongxp we have you covered.
Audits
At Orion Consulting we have built a strong team of GxP audit professionals with decades of experience in GMP and GDP inspections of pharmaceutical and API manufacturers and 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.
Orion GXP can help you
We can assist with a variety of services from 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), ISO13485 (medical device), or other regulatory standards to be applied. We have a panel of expert technical writers 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 subject matter experts can offer.
Orion Consulting can assist with all manner of validation projects, from facility commissioning and temperature mapping to systems and 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.
- 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.