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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