PSI International - TobaccovigilancePSI International - Tobaccovigilance
PSI International – Tobaccovigilance
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FEATURED PROJECTS

Tobacco, Pharmaceutical and Bio Product Approval Service

Tobacco, Pharmaceutical and Bio Product Approval Service

OVERVIEW

PSI is partnered with multinational tobacco companies to assist them with FDA permissions and approvals process and FDA Adverse Event Reporting Systems.

PSI will also provide the services mentioned above for e-cigarette companies as the FDA, in 2016, extended its authority to regulate electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among other.

PSI has past delivery experience in providing FDA permissions and approvals service to the UK and Indian pharmaceutical companies.

PSI provides prompt and accurate FDA permissions and approvals services for companies developing a new drug and/or for medical device manufacturers trying to take their new medical device to the US market.

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PSI NEWS
  • Tobacco Reporter magazine features PSI
    September 26, 2019
  • WORKSHOP ON FDA’s Center for Tobacco Products’ PMTA Best Practices
    August 22, 2019
  • PSI has attended the The Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting
    March 5, 2018
CONTACT US
  • Phone number:
    +1 703-352-8700
  • Fax number:
    +1 703-352-1170
  • E-mail:
    thodge@PSIINT.com
  • Contact:
    Thomas Hodge
  • PSI INTERNATIONAL, Inc.
  • Address:
    11200 Waples Mill Road, Suite 200, Fairfax, VA 22030
OUR PRODUCTS & SERVICES
  • Tobaccovigilance

    1. Support Regulatory Compliance Activities
    2. Implement Components of the Tobacco Control Act (TCA)
    3. Capture, Analyze, and Trend Adverse Health Effects and Product Quality Complaints
    4. Training Internal Staff on Use of MedDRA (FDA Regulatory Terminology)

  • Call Center

    1. Data Repository (PSI TIMES Tool) – Tailored Solution: PSI site or Client site
    2. Intake, Logging, Assessment, and Trending for Consumer and Clinical Research Calls

PSI NEWS
  • Tobacco Reporter magazine features PSI
    September 26, 2019
  • WORKSHOP ON FDA’s Center for Tobacco Products’ PMTA Best Practices
    August 22, 2019
  • PSI has attended the The Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting
    March 5, 2018
PSI International - Tobaccovigilance
2018 PSI International, Inc.

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