FDA Quality and Regulatory Consultants LLC

Management Consulting

Headquarters: 100 E. Whitestone Blvd, Suite 148-262, Cedar Park, Texas, 78613

Phone: +12145290248

Website: www.fdaqrc.com

Founded: 2009

Employees: 11-50

Stock Exchange: NA

About FDA Quality and Regulatory Consultants LLC

FDA Quality and Regulatory Consultants LLC offers specialized quality consulting, regulatory compliance and quality assurance fo ... r 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; Establishing Quality Assurance and Quality Control functions; Knowledge and application of ASTM & ISO standards covering both small molecules biologics; Risk assessment and developing Quality Risk Management Systems; Process Analytical Technology (PAT); Quality by Design (QbD); Process Validation; Training; Preparation and Review of FDA Regulatory Submission including 510k, PMA, NDA, ANDA, IND, IDE, DMF, and Prior Approval Supplement (PAS) applications; Inspectional Observations (e.g. 483 observations) and Warning Letters responses. Show more

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Frequently Asked Questions Regarding FDA Quality and Regulatory Consultants LLC

Where are FDA Quality and Regulatory Consultants LLC’s headquarters?

FDA Quality and Regulatory Consultants LLC’s headquarters are in 100 E. Whitestone Blvd, Suite 148-262, Cedar Park, Texas, 78613

What is FDA Quality and Regulatory Consultants LLC’s industry?

FDA Quality and Regulatory Consultants LLC is in the industry of: Management Consulting,Pharmaceuticals

What is FDA Quality and Regulatory Consultants LLC’s phone number?

FDA Quality and Regulatory Consultants LLC’s phone number is +12145290248

What is FDA Quality and Regulatory Consultants LLC’s official website?

FDA Quality and Regulatory Consultants LLC’s official website is www.fdaqrc.com

How many employees are working in FDA Quality and Regulatory Consultants LLC?

FDA Quality and Regulatory Consultants LLC has 11-50 employees

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