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Mock Audits

Tactical Remediation

FDA 483 strategic responses

Inspection readiness

Talent Solutions

Remediation Activities Plan

Batch Record Certification

Technical Writing

SOP’s Revision

Investigations Review

New Drugs Applications (NDAS)

Personnel Qualification

Project Management

CAPA Verifications

Quality System assessments

Change Management Initiatives

Visual Inspection

Strategy

Risk Assesments

Abbreviated New Drugs Applications (ANDAs)

Trainings/Education

Staff Augmentation Services

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