- EPA Air Emissions Test Methods
- EPA Agency-Wide Quality Documents
- EPA Antimicrobials
- EPA Ecotox Database
- EPA Electronic Pesticide Registration Submissions
- EPA Employee Directory
- EPA Enforcement Response Policies
- EPA Envirofacts Master Chemical Integrator
- EPA Environmental Models
- EPA FIFRA Scientific Advisory Panel
- EPA Food and Feed Commodity Vocabulary
- EPA GLP Advisories
- EPA GLP List of Inspections
- EPA Home Page
- EPA IRIS Toxicology Reviews
- EPA Office of Acquisition Management
- EPA Office of Enforcement and Compliance Assurance
- EPA OCSPP Harmonized Test Guidelines
- EPA Office of Pesticides
- EPA Restricted Use Products
- EPA Science Policy Issues
- EPA SW-846 online
- EPA Tolerance Reassessment & Reregistration
- National Pesticide Information Retrieval System
- Endocrine Disruptor Screening SEP
- Environmental Fate Database
- Pesticide Product Label System (PPLS)
- PhysProp Database
- Study Report Templates
U.S. Environmental Protection Agency
U.S. Food and Drug Administration
- CDER Guidance Documents
- CDER Home Page
- CDER New and Generic Drug Approvals
- CDER Regulatory Information
- CDRH Device Advice
- CDRH Device Training Courses
- CFSAN HACCP Home Page
- CVM Guidance Documents
- FDA Basics For Industry
- FDA Compliance Program Manual
- FDA FOIA Warning Letters
- FDA Guidance Documents
- FDA Industry Portal
- FDA Pesticide Analytical Manual
- FDA’s GCP Guidance
- FDA’s List of Disqualified Clinical Investigators
- FDA Debarment List
- GCP Regulations
- HHS Office for Human Research Protections (OHRP)
- HHS Personnel Directory
- Non-Clinical GLP Inspections Outcome
- Comparison of GLP between FDA, EPA, and OECD
- Inspections, Compliance, Enforcement, and Criminal Investigations (ICECI)
- ICECI Compliance Policy Guides
- FDA FOIA Frequently Requested 483
- ICECI Inspection Reference Documents
Pesticide Regulatory Files Review
QAI has reviewed hundreds of pesticide regulatory files for compliance with EPA’s Label Review Manual and PR Notice 98-10. Our team includes industry professionals with extensive backgrounds in regulatory affairs and formulation chemistry. QAI can conduct a similar review of registration, production, and advertising files for EPA-registered products to preemptively identify potential regulatory problems, and correct procedures before possible EPA intervention. Tasks include:
- A complete review of the submissions to EPA, and of EPA’s responses.
- A complete review of all final printed labels, and submissions to States.
- A complete review of the CSF and formulations “recipes”, including documentation of suppliers.
- A complete review of Quality Control analysis results.
- A complete review of all labeling and advertising, including promotional materials.
Other Resources
- American Association of Pharmaceutical Scientists
- American Chemical Society
- AOAC Home Page
- ASTM Home Page
- CDMS Pesticide MSDS
- Chemical Producers & Distributors Association
- CropLife America
- EXTOXNET Toxicology
- IR-4 Home Page
- ISO 17025 Accreditation Bodies and Information
- Keller & Heckman Home Page
- Nelac Institute
- Monsanto’s ag Biotechnology Page
- National Pesticide Information Center
- Parenteral Drug Association
- Pesticide Active Ingredient Information
- Regsource – Regulatory Resources
- SQA Home Page
- Toxicology Data Network
- U. of Akron Chemical Database
