Compliance to FDA & EU Requirements

· Start-up quality system implementation

· Upgrade to ISO 13485:2003

· CE Marking

· Gap analysis evaluation of existing systems

· Performing a regulatory due diligence for acquisitions

· Technical writing of policies and procedures

· Designing, revamping and instituting quality systems processes

· Risk Management throughout product life cycle

· Various levels of Compliance Training

BQC consulting

 

Biotech Quality & Compliance

 

 

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