Quality systems, audits and inspections
We assess processes, documentation and facilities, support inspection readiness and help implement the agreed improvements.
Manufacturing and facilities
For medicines, we assess raw-material sources, technology, the manufacturing chain, certificates and licences. For devices, quality system and inspection requirements depend on the product and procedure.
Quality systems and documentation
We support quality system implementation and improvement, procedures and documentation. Veterinary projects can include qualification, validation and CAPA within the agreed programme.
Audits and inspection support
We provide pre-inspection preparation, audits and on-site or remote inspection support, using our team or partners as appropriate. Research projects can include applicable GCP and GLP audits.
How we can support you
An individual document, study, project stage or complete programme. We agree source data, deliverables, timelines and responsibilities before work begins.
Where do we start?
Tell us about your product and objective. We will assess the available information, identify what is needed and agree the right scope of work.