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Remote Services
Quality Systems Implementation and Remediation
Policy, Standard, SOP writing
Due Diligence Assessments
Application (ANDA, NDA, 510K, DMF, etc.) review and assembly
CAPA plan reviews
Investigation reviews and writing
Batch record reviews for product disposition
Data Integrity Reviews – Lab and Manufacturing
Training
Annual GMP Training and certification
FDA Meeting Preparation
483 and Warning Letter Responses
Supplier Quality Management
Quality Agreements
Device Design History Files
Analytical Method Review
Design of Quality Organization for sustainable compliance
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