PROJECT MANAGEMENT

The LANDIS staff has extensive experience in all of the agricultural disciplines and has been managing products through the regulatory process for almost 40 years; this includes the United States Federal and State agencies, Canada, Australia and Europe. We also offer a wide range of services designed to meet the varying product development and studies management needs of our clients, including:

  • Protocol Development
  • Radio-labeled studies
  • Contract report writing
  • Environmental safety studies
  • Formulation development and evaluation
  • Non-target organism studies
  • Product chemistry studies
  • Worker and reentry exposure studies
  • Toxicology studies
  • Efficacy testing in greenhouse and field
  • Residue chemistry studies
  • Contract GLP field and Laboratory audits

We have experience with the registration and testing requirements for not only classical pesticide compounds, but for biochemical and biological products, as well.

EPA SUBMISSIONS

EPA Submission experiences with the EPA include, but are not limited to:

  • New Chemical Active Ingredients
  • New Biologicals
  • Section 18 Emergency Exemptions
  • Section 24c Special Local Needs Registrations
  • Import Tolerance Submissions
  • BPPD Biochemical Registrations
  • Follow-On Registrations (Me-Too)
  • End-Use Product Registrations
  • Inert Tolerance Petitions
  • Inert Exemptions from Tolerance
  • RED Management / Registration Review
  • Risk Assessments
  • Reduced Risk Petitions
  • Antimicrobial Submissions

CANADA – PMRA SUBMISSIONS

Canadian Experience with PMRA includes but is not limited to:

  • New Active Ingredients
  • End-Use Product Registrations
  • Program 914 Submissions
  • Research Authorizations
  • Risk Assessments
  • Reduced Risk Petitions

GLOBAL SUBMISSIONS

GLOBAL Submission experiences include, but are not limited to:

  • New Chemical Active Ingredients
  • End-Use Product Registrations
  • Program 914 Submissions
  • Risk Assessments
  • Reduced Risk Petitions
  • GLOBAL submissions to CODEX, JMPR, WHO-PQ and JMPS.
  • Collaboration for submissions to Europe, Brazil, Mexico, Australia and Japan.

REGULATORY CONSULTING

EPA Submission experiences with the EPA include, but are not limited to:

  • New Chemical Active Ingredients
  • New Biologicals
  • Section 18 Emergency Exemptions
  • Section 24c Special Local Needs Registrations
  • Import Tolerance Submissions
  • BPPD Biochemical Registrations
    • Follow-On Registrations (Me-Too)
  • End-Use Product Registrations
  • Inert Tolerance Petitions
  • Inert Exemptions from Tolerance
  • RED Management / Registration Review
  • Risk Assessments
  • Reduced Risk Petitions

REGULATORY ADMINISTRATION

Regulatory administrative activities include, but are not limited to:

  • EPA Production Facility Establishment Registration applications
  • EPA Pesticide Report for Pesticide Producing and Device-Producing Establishment Report submissions
  • EPA Company number applications
  • EPA Maintenance Fee reporting

US STATE REGISTRATIONS

US State Registration activities include, but are not limited to:

  • New Pesticide Registrations in all 50 States, Washington D.C. and Puerto Rico
  • New Fertilizer Registrations in all 50 States, Washington D.C. and Puerto Rico
  • New Feed Registrations in all 50 States, Washington D.C. and Puerto Rico
  • Renewal applications for pesticide, fertilizer and feed products in all 50 States, Washington D.C. and Puerto Rico
  • State Tonnage Reporting
  • State Sales Reporting