Efficacy Studies

Home > Regulatory Consulting

ICR's regulatory consultants can help clients obtain and maintain registrations with U.S. EPA and Canada's PMRA for active ingredients, concentrates and end use products. We are also capable of obtaining and maintaining state registrations, tracking new requirements and trends in regulatory authorities and acting as official agents for overseas clients in dealings with US and Canadian regulatory agencies. More detailed information can be found below.

U.S. EPA Registrations

  • Take a new active ingredient from an initial screen to EPA registration, and register concentrates and end use products
    • Advise on data required
    • Meet with EPA to determine data requirements
    • Monitor data generation
    • Assemble, review and submit application package to EPA
    • Follow application through the EPA review process
    • Respond to EPA questions
  • Support and maintain products after registration
    • Respond to EPA PR notices
    • Respond to data call-ins
    • Respond to re-registration requirements
    • Track and respond to other new EPA requirements
    • Label revisions
    • Formulation changes
    • Pay EPA maintenance fees
    • File annual production reports with EPA
    • File TSCA 8(e) reports
  • Support basic producer sales
    • Me-too registrations
    • Subregistrations
    • Letters of authorization to cite client data to support customer end use products
    • Arrange R&D sample imports to customers

PMRA/Canada registrations:

  • Take new active ingredient from initial screen to PMRA registration, and register concentrates and end use products
    • Advise on data required
    • Meet with PMRA to determine data requirements
    • Monitor data generation
    • Assemble, review and submit application package to PMRA
    • Follow application through the multi-step PMRA review process
    • Respond to PMRA questions
  • Support and maintain products after registration
    • Respond to Directives and other notices
    • Respond to re-evaluation requirements
    • Track and respond to other new PMRA requirements
    • Label revisions
    • Formulation changes
    • Pay PMRA maintenance fees
  • Support basic producer sales
    • End use product registrations
    • Letters of authorization to cite client data to support customer end use products
    • Letters confirming source of active ingredient

State and Provincial Registrations

  • Register products in states: states requiring data (e.g. California, New York, Florida) as well as those requiring only administrative forms
  • Register products in Canadian provinces