Next Upcoming Event
You don’t have to figure it out alone
Our team can provide support for:
Inspection preparation
- We help get sites ready for Regulatory and Corporate inspections, including working with groups to get their own areas ready. We can also assist behind the scene during the inspection itself.
Inspection remediation
- Unfortunately, not all audits go well, but we can help get sites that have had poor inspections back on their feet. We can help you elaborate the CAPA and implement it.
We provide CONSULTANCY services to:
- Assess compliance with the GMP/GDP regulation of facilities, personnel and processes
- Provide assistance with the necessary documentation (Site Master File) for various authorizations submissions
- Layouts review, personnel and material flows for a new project or adequacy of an existing zone
- Compliance of products regulation with special requirements for new projects or areas
- Provide expertise regarding protocols for validation (process, cleaning, computerised system, sterilization) and media fill
- Elaboration of procedures relating to a particular area or process