Compliance

 Do you want to achieve pharmaceutical accreditation status but do not know where to start? We help facilities receive PCAB, NABP, or URAC accreditation. Our compounding consultants have trained at ACHC to be either surveyors or certified PCAB consultants. The cGMP Compliance Group conducts accreditation inspection readiness audits and will assist you to  prepare your facility to meet the standards. 

 Is your compounding operation cGMP, FDA, DEA, Board of Pharmacy, USP, PCAB, or NABP compliant? Ready for your next regulatory or accreditation audit? Our experts are compounding veterans, having spent their careers in 503A, 503B, and pharmaceutical manufacturing settings. Contact The cGMP Compliance Group today. 

 The cGMP Compliance Group provides litigation support services in matters of 503A pharmacy and 503B outsourcing facility compounding laws and regulations. We provide expert witness depositions, testimony, evidence review and detailed reports specific to the issue. If your compounding operation has been hit with legal issues, our expert witnesses and probationary consultants can help. 

 Pharmacies and outsourcing facilities seeking licensure in multiple states will face unique licensing requirements in each state they serve. Let us help you obtain and manage your licenses and registrations so you can focus on what you do best! 

If your organization has been hit with a FDA Form 483, warning letter, or Board of Pharmacy accusation or plan of correction mandate, you don’t have much time to respond and correct the deficiencies. The cGMP Compliance Group can support you through this difficult time. 

 The FDA is cracking down on API suppliers. Almost daily, pharmaceutical firms broadcast recall alerts for their FDA approved drug products. Our consultants have extensive audit and GMP experience. Don’t take time away from your operation. Let us take the guess work out of auditing your critical compounding material suppliers.