Good Manufacturing Practice (GMP)-
– NUVO Consultancy offers various GxP services like GMP Audits, computer system validation.
– Pre-inspection audits for WHO, USFDA, EU, ANVISA, TGA and all other health authorities.
– Health authority inspection Compliance and support, Implementing and monitoring the Quality Management system (QMS).
– Vendor Audits for Formulation, API, Intermediates, Excipients, Raw materials, packaging material.
– Computer system validation (CSV), execution & compliance
– Routine GMP audits & compliances
– GAP assessment audit services
– Data Integrity compliance and Supporting Document s Auditing
– Inspection Readiness / Pre-Approval GMP Inspection Audits
– GMP Quality Systems improvement As per ICH Q8;Q9;Q10 (PQS)
– Serving for your External audit observations compliance and Monitor the CAPA
– Qualification and cleaning validation as per latest ADE/PPE concept
– Bioequivalence studies monitoring and CRO /study audits