Fda Quality And Regulatory Consultants LLC
Homepage http://www.fdaqrc.com
LinkedIn Profile https://linkedin.com/company/fda-qua***atory-consul***
HQ Location
United States , Texas, Cedar Park100 E. Whitestone Blvd Suite 148-262 Cedar Park, Texas 78613 United States
FDA Quality and Regulatory Consultants LLC offers specialized quality consulting, regulatory compliance and quality assurance for Pharmaceutical, Medical Device and Biotech companies. We provide customized, value-added solutions, processes and enhanced quality standards to optimize business efficiencies and minimize regulatory risk.
Our associates have years of experience as Consumer Safety Officers (Investigators), Center Personnel for the United States Food and Drug Administration (FDA) and industry experts responsible for international Quality System Regulation/ current Good Manufacturing Practice (QSR/cGMP) inspections of pharmaceutical and medical device manufacturers, Biomedical Monitoring / Good Clinical Practice (BIMO/GCP) and Good Laboratory Practice (GLP) audits.
Services include:
Good Manufacturing Practice (cGMP) and pre-inspection readiness audits;
Preparation for Pre-Approval Inspections (PAI);
Development and assessment of bioassay, bioanalytical, and analytical methods;
Establishi
Pharmaceuticals and Medicine Manufacturing
The Drugs and Medicine industry involves research, development, manufacturing and distribution of pharmaceutical drugs and medicines. Companies in this field focus on preventing and treating illness using medicinal compounds and therapies.
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