Regulatory Consulting

Study planning and careful design are essential in the undertaking of new registrations.

LANDIS offers support in the following areas during this critical phase of product development:

  • Interpretation and analysis of regulations
  • Design of product registration programs
  • Study protocol development
  • Liaison between client and regulatory agencies
  • Negotiation of registration requirements with regulatory agencies

In addition to the above activities, LANDIS provides:

  • Task force representation and management
  • Scientific and regulatory compliance data review
  • Data compensation evaluation

Once the regulatory strategy has been defined, LANDIS provides the following in order to complete your registration objectives:

  • Preparation and defense of applications for registration, re-registrations, and amended registrations
  • Petitions for Tolerances
  • Import Tolerances
  • FQPA Summaries
  • Inerts clearances
  • Registration and label maintenance
  • State registrations

LANDIS has made the following regulatory submissions:

  • New Chemical Active Ingredients
  • New Biologicals
  • Section 18 Emergency Exemptions
  • Section 24c Special Local Needs Registrations
  • Import Tolerance Submissions
  • BPPD Biochemical Registrations
    *First Bioengineered Field Trial Approval in the U.S.
  • Follow-On Registrations (Me-Too)
  • End-Use Product Registrations
  • Inert Tolerance Petitions
  • Inert Exemptions from Tolerance
  • Program 914 Submissions
  • RED Management / Registration Review
  • Risk Assessments
  • Reduced Risk Petitions
    *Electronic Submissions