Quality / Regulatory

We are closely associated with a Regulatory service support partner to offer Quality/Regulatory Services. Listed below are some of them for reference.

• Review of NCEs, NMEs Chemistry and Manufacturing Controls (CMC)
• Design, Review and Qualification of Mfg., Laboratory, Packaging facilities
• Remediation of existing facilities to bring in compliance with QA/RA.
• Gap analysis
• Technology transfers, Batches execution, For-cause audits etc.
• Due diligence audits
• Clinical audits (GCP)
• Quality and Regulatory consultation during development of NCEs/NMEs
• Development Quality Assurance and RA
• CAPA management for clients
• QbD consultation