Regulatory

Quality, Compliance, GMP and Audit Management
Audit Management & QMS Reviews – Internal Audits, Regulatory Inspections and Customer Audits
Data Integrity and ALCOA evaluations in sites
Market Complaints handling and Pharmacovigilance activities and Recall handling.
Computer system validations and electronic data controls
PAT controls, QbD
Sterile Operation Controls and Validations
Protocol Development and review of Pre-clinical and Clinical activities.
Remedial Measures: CAPA Implementations & Evaluations
Gap assessment - Facilities and Products, GLP and GMP compliance.

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