Regulatory Studies

Environmental Fate / Residue Chemistry

Degradation (Hydrolysis, Photodegradation)
Aerobic and Anaerobic Metabolism (Soil, Aquatic)
Mobility (Absorption/Desorption, Soil Column Leaching, Lab Volatility)
Field Soil Dissipation Prospective/Retrospective Groundwater
Fish Bioaccumulation (Metabolite Identification)
Confined Accumulation (Rotational Crop)
Field Rotational Crop

Nature of the Residue

Plant Metabolism
Metabolite Identification
Distribution Studies
Reincorporation Methodology ( 14 C)

Animal Metabolism
Nature of the Residue (Goats, Poultry)

Magnitude of the Residue
Crop Field Trials & Storage Stability
Livestock Feeding Studies (Cattle, Poultry)
Market Basket Surveys
Independent Laboratory Validations (ILV)

Toxicology

Acute
Oral and Dermal LD50
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization

Subchronic
21- and 90-Day Dermal
90-Day Gavage
90-Day Dietary

Chronic Toxicity/Oncogenicity

Single and Multi-generation Reproduction

Neurotoxicity
Developmental
Functional Observation Battery
Motor Activity Assessment

Target Animal Safety

Animal Metabolism

Absorption, Distribution, Excretion
Single and Multiple Dose
Oral, Dermal, IP, IV

Special Surgical Techniques
Bile Duct Cannulation
Jugular Cannulation
Metabolite Identification/ Quantitation

Product Chemistry

Product Chemistry Packages (Active Ingredient, Formulation)
Methods Development and Validation
GLP Characterization Test, Control, Reference Substances
Certificate of Analysis (FIFRA, TSCA, OECD, J-MAFF Requirements)

Problem Solving
Deformulations
Trace Impurity Isolation/Identification

Technical Support of Registration Packages

Program Management and Consulting
Project Coordination
Technical-Regulatory Agency Interface
Scientific Soundness Review of Registration Packages (U.S., Canadian, European, J-MAFF)

Study Package Assembly
Dossier preparation (EU, Canada)
Post-FQPA Registration Issues (U.S.)
Modeling & Risk Assessments

Synthetic Chemistry
Analytical Standards, Model Compounds, Metabolites
Radiolabel Synthesis

Process Services

Material Preps
(grams to kgs to metricTons)
Product Candidates
Intermediates
Process Discovery, Development, and Optimization
Contract Manufacturing