GxP SME Support
Subject Matter Expert support
Orion Consulting specialises in providing subject matter experts to assist with technical operations in the pharmaceutical industry including; process optimisation, development/scale-up, technology transfer, sterility assurance, formulation development, validation and NPI project management. Whether it is scale up from the R&D lab to the industrial plant, or moving a process from one CMO to another due to performance or cost concerns. Our technical transfer experts are on hand to clearly map out the transfer process and to carefully select and carry out good due diligence of CMO partners with the right experience in developing the drug dosage form you are looking to transfer.
Facility Design Reviews
If you are at the facility design stage we can assist in reviewing your proposed designs to ensure regulatory compliance and efficient layout for process and personnel flows. We can provide an independent assessment to verify that all regulated requirements are adequately covered during the design phase.
Our subject matter experts will assess your proposed facility design and will verify compliance with the appropriate ISO/GMDP/ICH standards to set your facility up for future sucess.
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.
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 got you covered.
At Orion Consulting we have built a strong team of GxP audit professionals with decades of experience in GMP inspections of global active pharmaceutical ingredients.
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.