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    Fda Quality And Regulatory Consultants Llc

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    Description

    • 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;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.
    • location

      Headquarters:100 East Whitestone Boulevard Suite 148-262, Cedar Park, Texas, United States

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    • Fda Quality And Regulatory Consultants Llc phone

      Phone Number: +1 214-529-0248

    • Fda Quality And Regulatory Consultants Llc website

      Website: https://www.fdaqrc.com

    • Fda Quality And Regulatory Consultants Llc employees

      Employees:33

    • Fda Quality And Regulatory Consultants Llc revenue

      Revenue:$1 - 10M

    • Fda Quality And Regulatory Consultants Llc legal name

      Legal Name:Fda Quality And Regulatory Consultants Llc

    • Fda Quality And Regulatory Consultants Llc's Social Media

      Fda Quality And Regulatory Consultants Llc linkedin Fda Quality And Regulatory Consultants Llc facebook Fda Quality And Regulatory Consultants Llc twitter
    • done Is this data correct?

    • |  NAICS Code: 541320  |

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    Person level website identification

    Vice President for Fda Quality And Regulatory Consultants Llc

    Michelle Thompson

    Vice President

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    View Employees

    Michelle Thompson

    Vice President

    Michelle Holbrook

    Vice President

    Bessie Cook

    Eeo And Diversity Workforce Director

    Hashem Aqrabawi

    Managing Director

    Kim Oldham

    Project Manager And Csv Auditor

    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 East Whitestone Boulevard Suite 148-262,Cedar Park,Texas,United States

    • What is Fda Quality And Regulatory Consultants Llc's phone number?

      Fda Quality And Regulatory Consultants Llc's phone number is +1 214-529-0248

    • What is Fda Quality And Regulatory Consultants Llc's official website?

      Fda Quality And Regulatory Consultants Llc's official website is https://www.fdaqrc.com

    • What is Fda Quality And Regulatory Consultants Llc's Revenue?

      Fda Quality And Regulatory Consultants Llc's revenue is $1 - 10M

    • What is Fda Quality And Regulatory Consultants Llc's NAICS code?

      Fda Quality And Regulatory Consultants Llc's NAICS code is 541320

    • How many employees are working in Fda Quality And Regulatory Consultants Llc

      Fda Quality And Regulatory Consultants Llc has 33 employees

    • What is Fda Quality And Regulatory Consultants Llc's Industry?

      Fda Quality And Regulatory Consultants Llc is in the industry of Pharmaceuticals

    • Who is Fda Quality And Regulatory Consultants Llc's Vice President?

      Fda Quality And Regulatory Consultants Llc's Vice President is Michelle Thompson

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