Is your department prepared for a visit from the FDA, DEA or other government agency?
Are your vendors performing services in accordance with applicable laws and established business rules?
Are the systems utilized for regulated activities properly validated?
Do you have effective and comprehensive Standard Operating Procedures in place?
Are you in the process of Vendor Selection and in need of an expert eye?
Do you need to respond to a FDA 483?
G&M Health’s robust Audit and Assessment service can answer these questions!
FDA / DEA Mock Audits
GxP Audits
Software and Infrastructure Assessments
Training Records and Standard Operating Procedures Review
Coupon / Voucher / Copay Card Audits
Representation During CIA, FDA, DEA and State Audits