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Quality Managemenet System (API/Formulations)
Regulatory Inspections & Remidiations Plans
QMS Gap Assessments>Data integrity audits
Computrized systems validations (CSV) & Gap Assessments
Qualifications and Validations>Expert in GxP investigations
Expert in Contract Manufacturing Units (CMU)
Expert in Vendir Qualifications
Expert in Regulatory filling
Expert n facility design
Expert in Engineering Services
Expert in Research & Development
Experrt in Operational excellence
Expert in technical writing
Expert in Process and cleaning validations