Expertise

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21 CFR 210/211  

21 CFR Part 58  

OOS/OOT Investigations 

Implementation of Part 11 Compliant Computer Systems  

Hosting FDA and Client Audits 

Method Development and Validation

ICH Q7, Q8, Q9, Q10, Q11  

API Manufacturing 

Deviation, CAPA, and Investigations 

Vendor Management 

Quality Agreements 

Client Relationships

Implementation and Management of Pharmaceutical Quality Systems 

Drug Product Manufacturing 

Change Control 

Vendor Audits 

Batch Release 

Formulation Development