GxP Compliance Group (GCG), is a global consortium of senior GxP professionals specializing in inspection readiness, audits, and compliance strategy across cGMP, GCP, GLP & PV functions of drug product development.
Extensive hands-on experience managing regulatory inspections across multiple jurisdictions (e.g., FDA, Health Canada, MHRA, EMA, PMDA, NMPA, MFDS, ANVISA & CDSCO) and help clients to confidently interact with regulatory authorities and succeed in inspections.
Provide integrated GxP support with global reach across North America, Europe, and Asia-Pacific.
Provide end-to-end support for management of GxP audit program (planning, execution, reporting, CAPA and EC) to support clinical development and commercialization.
Our services are offered as standalone engagements or fully integrated GMP–GCP–GLP programs, tailored to your pipeline and risk profile