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