Denise Smart

Denise Smart Email and Phone Number

President of Smart Consulting Group, a WBENC Certified, Life Sciences Consulting firm in operation for 20+years. @ Smart Consulting Group, LLC
pecs, hungary
Denise Smart's Location
West Chester, Pennsylvania, United States, United States
About Denise Smart

As President of Smart Consulting Group, I have over 30 years’ of Life Science industry-specific manufacturing and quality experience with such companies as SmithKline Beecham, DuPont, Wyeth, Pfizer and Schering-Plough. With a broad range of experience in providing FDA regulatory compliance consulting services, I have a true passion for providing solutions to the Life Sciences industry's most difficult and complex challenges. I hold a BS in Biology from Kutztown University, a MBA from Penn State, and a JD from Widener Law School. I have been admitted to the Delaware Bar and the Federal District Court, District of Delaware. While attending Widener University School of Law, I realized my instinctual passion for health and corporate law, which led to a desire to start my own pharmaceutical consulting firm right in the borough of West Chester, Pa. I am a certified Women’s Business Enterprise (WBENC) business owner, meaning that I am dedicated to continually gaining relationships with local women owned businesses as a way to ultimately provide a sense of community for women entrepreneurs in the region, like myself. My expert team at Smart Consulting Group focuses on quality compliance, regulatory affairs, training, product/process development/manufacturing, laboratory services, project management. The SCG team also provides highly specialized services to the government supporting the Biological Advanced Research and Development Authority (BARDA) within HHS, serving as Interim Monitor of pharmaceutical divestitures for Federal Trade Commission and providing strategic regulatory compliance advice to the FDA. I am dedicated to providing outstanding technical and regulatory services to SCG’s client base as a way to truly change the nature of this industry.

Denise Smart's Current Company Details
Smart Consulting Group, LLC

Smart Consulting Group, Llc

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President of Smart Consulting Group, a WBENC Certified, Life Sciences Consulting firm in operation for 20+years.
pecs, hungary
Employees:
16
Denise Smart Work Experience Details
  • Smart Consulting Group, Llc
    President
    Smart Consulting Group, Llc Jan 1998 - Present
    Provide regulatory compliance consulting services to the FDA.Project Leader for assessment and remediation of Quality Management and Quality Assurance Systems and Post-Market Safety Surveillance systems. Expertise in design of Quality Management Systems for clinical and commercial products for the global market. Expertise in development and implementation of company Quality Program strategies for partially or fully outsourced operations.Interim Monitor for the Federal Trade Commission for Pharmaceutical / Life Science Product Divestitures. Review Respondent and Acquirer activities in view of obligations in FTC Orders and divestiture agreements.. Lead activities of technical and regulatory resources to evaluate compliance. Facilitate discussion and resolution of issues between parties and at the direction of the Commission. Manage and conduct due diligence activities for acquisition or licensing of pharmaceutical and biotechnology products. Manage personnel and provide advice in support of contract with HHS/ASPR/BARDA to provide Subject Matter Experts for Medical Countermeasure development.Bar Admissions: Delaware, 2000 United States District Court for District of Delaware, 2001Regulatory Affairs Certified (1992)
  • Smithkline Beecham
    Patent Associate
    Smithkline Beecham Jan 1997 - Dec 1997
    Drafted responses to PTO office actions for biotechnology patent applications.Reported on impact of genetic information privacy legislation on R&D activities.Wrote opinions on legal issues pertaining to pharmaceutical and biotechnology drug development.
  • Smithkline Beecham
    Manager
    Smithkline Beecham 1989 - Dec 1996
    Managed Biopharmaceutical Quality Assurance Department for Clinical Supplies
  • Triad Technologies
    Fda And Validation Consultant
    Triad Technologies 1987 - 1989
  • Dupont
    Scientific & Quality Positions
    Dupont 1983 - 1987
    Quality and Regulatory Specialist for Autologous Cell Therapy Facility Supervisor, Pilot Scale Protein Purification FacilityQC Lab Tech, HIV Clinical Test Kit DevelopmentCell Culture and Assay Development Technician

Denise Smart Skills

Fda Biotechnology Gmp Pharmaceutical Industry Validation Regulatory Affairs Biopharmaceuticals Quality System Lifesciences Quality Control Technology Transfer Quality Assurance Drug Development Change Control 21 Cfr Part 11 Glp Life Sciences U.s. Food And Drug Administration R&d Capa Clinical Trials Regulatory Submissions Biologics Software Documentation Intellectual Property Corrective And Preventive Action Good Laboratory Practice Standard Operating Procedure Research And Development Quality Auditing Clinical Development Medical Devices

Denise Smart Education Details

Frequently Asked Questions about Denise Smart

What company does Denise Smart work for?

Denise Smart works for Smart Consulting Group, Llc

What is Denise Smart's role at the current company?

Denise Smart's current role is President of Smart Consulting Group, a WBENC Certified, Life Sciences Consulting firm in operation for 20+years..

What is Denise Smart's email address?

Denise Smart's email address is de****@****grp.com

What is Denise Smart's direct phone number?

Denise Smart's direct phone number is +161091*****

What schools did Denise Smart attend?

Denise Smart attended Widener University School Of Law, Penn State Great Valley, Kutztown University Of Pennsylvania, Penn State Great Valley.

What skills is Denise Smart known for?

Denise Smart has skills like Fda, Biotechnology, Gmp, Pharmaceutical Industry, Validation, Regulatory Affairs, Biopharmaceuticals, Quality System, Lifesciences, Quality Control, Technology Transfer, Quality Assurance.

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