USA HeadquartersTel: + 1 253 473 9007European HeadquartersTel: +
44 131 445 6080
[email protected]
Offices in the USA and Europe
Biorational / BiopesticideServices
EPA Biorational / Biopesticide Registration
Regulatory Guidance and Support
Regulatory and environmental strategies for microbial products
(bacteria, viruses, fungi, and nematodes), biochemical products
(plant and insect growth regulators, hormones, botanicals, and
pheromones), plant-incorporated protectants (PIPs - pesticidal
substances produced by plants containing added genetic material,
and other synthetic materials used for pest control. EPA liaison
and negotiation for expedited registrations; registration dossier
preparation and submission. Assistance with regulatory history,
Federal Register notices, and/or registrant and product lists.
Product registration guidance and support for reduced-risk and
minimum-risk products used for crop protection and home and garden
applications. Regulatory support for plant and insect growth
regulators; mite growth regulators; botanicals and florals; natural
toxicants; bacterial fermentation products; microbials; biochemical
pheromones; plant-incorporated protectants; and materials with
unique modes of action subject to pre-marketing approval by EPA,
State and International regulations. Regulatory submission and
management of organic certifications (NOP, OMRI, WSDA).
State and International Registration ManagementFirst-time
registration approvals and annual renewals in all 50 states,
District of Columbia, and US territories. State and international
agency liaison; submission of registration dossiers (registration
applications, labels, technical data/reports and safety data
sheets). Support for international registration requirements and
renewals, particularly Europe and Latin America.
Data Development / Study Monitoring Identification of required
studies to support biorational / biopesticide registration
requirements for product composition, toxicity, degradation, and
other characteristics. Support for data gap analysis, placement and
monitoring of studies at contract research organizations, review
and interpretation of study results, compliance with technical
guidelines and Good Laboratory Practice (GLP) standards.
Regulatory and Scientific Insights Advice on emerging regulatory
and scientific policies that may impact current and future
biorational / biopesticide registrations. Recommended approaches to
bring client products into compliance with new regulations.
Cost-effective Consulting Supportfor Potential Fast-Track
Registrations
Regulatory and Scientific Specialists
COMPLIANCE SERVICES INTERNATIONALGlobal Regulatory and
Environmental Strategies since 1988
