BPIA Member Regulatory Consultants

Services Offered

Product Development

• Stage gate process management
• Strategic product planning and portfolio analysis
• Regulatory strategy and pathways
• Trial design management and product validation
• Data analysis, evaluation, and recommendations
• Technical positioning & Best Management Practices
• Technology transfer initiatives
• Agronomic consultative services

Business Development

• Strategic planning and consensus-building process
• Industry audits and surveys
• Technical due diligence
• Acquisition strategy, profiling and vetting
• AgriConnect™ agribusiness exploration

Market Development

• Go-to-market strategy and access
• Market potential and needs analysis
• Competitive intelligence
• Distribution & channel network evaluations
• Conquest customers & equity events
• Influencer relations

Sustainability Development

• Eco-system analysis
• Food & agriculture production optimization
• Technology transfer, training and extension

Services Offered

Entomological Expertise:

• Efficacy review for public health and agricultural pests
• Evaluate genetically engineered insects
• Pesticide benefit assessments
• Evaluate safety data for pollinators

Non-Target Organism Expertise:

• ​Ecological assessments and data waiver rationales
• Non-target organism data review

Pesticide Registration:

• Product registration and label review
• Provide data waiver rationales, data evaluations, risk assessments, and reports for pesticide registration and registration review for biopesticides and conventional pesticides.
• Prepare comment responses to Federal Register notices issued by EPA
• 73 years combined experience with the U.S. EPA’s Office of Pesticide Programs

Regulatory Services Offered 

Pesticide Registration:

• Product registration pathway strategy development for Section 3 products including biopesticide and conventional registrations
• Minimum risk products
• BPPD, RD, and State regulatory submission packages
• New active ingredient registrations
• Label authoring, analysis, and review
• Toxicology and physical chemistry data collection oversight and assessments
• Data waiver strategy development and authoring
• Protocol development for EPA compliant efficacy studies
• Human Subject Review Board (HSRB) submissions
• Prepare comment responses to Federal Register notices issued by EPA

Lab, Field and Semi-field product evaluations:

• ​In-house efficacy evaluations – knockdown, mortality, repellency
• Mosquito, tick, flea, and louse efficacy specialists
• Non-target organism toxicological data oversight and review
• Wind tunnel, Y-tube, flight chamber and arm-in-cage bioassays
• Mosquito larvicide efficacy bioassays

Product Development Expertise:

• In-house formulation services to meet your target product profile
• Formulation from initial concepts or for formulary improvement for Section 3 and 25(b) products
• Product efficacy data generated for product development & registration purposes
• Pesticide comparative evaluations – efficacy, costing, safety
• Extensive repellent and biopesticide development and regulatory experience – on-skin, spatial, surface applied, knockdown

Services Offered

Software Platform Services

Automated state registration tracking and renewal
Automated tonnage reporting and renewal
Registration dossier development and submission management
Label management
Regulatory data and documentation management
Registration tracking and management

Full Regulatory Support Services

Full registration services for Biopesticides, Antimicrobials, and Conventional Pesticide
State pesticide registration and maintenance
Biofertilizer/Biostimulant/Fertilizer registration and maintenance
Tonnage reporting
APHIS PPQ/BRS Permitting
EPA Biotech Notifications
TSCA TERA
Organic Certifications
Full US agent services

Services Offered

FIFRA Services

• Federal and State Registration & Maintenance (Pesticide / Antimicrobial / Biopesticide)
• Product Development & Registration
• Regulatory Guidance, Strategy, & Support
• Biological Product Registration, Federal & State (Biostimulant / Fertilizer / Plant & Soil Amendment)
• FIFRA Exempt Pesticides / 25(b) Products
• US/EU Agent Services (Pesticide Producing Establishment Registration & Reporting)
• Study Placement and Monitoring / Data Development
• Data Gap Analysis
• Strategy/Support for Data Call-Ins (DCI)
• Data Waiver Requests
• Tolerance Petition / Exemption Support (MRL)
• Risk Assessment (Ecological / Exposure Modeling)
• Litigation Support (Data Compensation / Intellectual Property / Expert Witness Testimony)

Other Services

• Organic Certification (OMRI, WSDA, NOP)
• International Registration Management (USA, EU, China, Taiwan, LATAM)
• TSCA Compliance (LVE, PMN)

Services Offered

• Biological and biostimulant registration, Federal and State
• New Active Ingredient Registration, Federal and State
• State Registrations for 25(b) products
• Registration, Get-to-Market Strategies
• Label Compliance
• Amendments and Notifications
• Ongoing Compliance Activities
• Re-registration and Data Call-ins
• Data Compensation Requests and Arbitration
• US Agent Services
• TSCA Compliance
• Preparation and submission of data rights transfers, tolerance petitions, formulator agreements, EPA Design for the Environment applications, notices of arrivals, Freedom of Information Act (FOIA) requests. OMRI Listing, NOP Label

Services Offered

Research and Consulting Services

• Global Regulatory Strategy and Label Development
• Custom Research / Single Client Studies
• Due Diligence
• Market Development/Go-To-Market Strategy
• Product Development
• Strategic Marketing Communications
• M&A Valuation Support
• M&A Matchmaking
• Formulation Support and Technology Scouting

Global Market Reports 

• Biocontrol
• Biostimulants
• Pheromones
• Biofertilizer
• Value-Added Fertilizer

Training/Education

• Custom Workshops
• Video Education and Training Programs

Services Offered

• Local and Global Regulatory Foresight:
• Regulatory advice & strategy
• Ad hoc regulatory support
• Portfolio impact analysis
• Technical / risk assessment
• Product life cycle assessment/footprinting
• Federal & State Registrations crop protection & biocides
• Technical Expertise
• Subject matter experts in all disciplines
• Supply chain support
• Due diligence and transaction advisory
• Digital solutions for data management
• Hazard communication / SDS’s
• Ag trade regulatory compliance
• Global Services:
• Market drivers and regulatory landscapes
• Low Carbon Economy Transition
• Green chemistry & product design processes
• Located in over 40 countries & territories
• 160+ Offices
• 5500+ Employees

Services Offered

FIFRA Support:

• Biochemicals
• Microbials
• Plant Incorporated Protectants
• Biochemical Classification Requests
• Registration Strategy
• Registration Support
• Study Placement and Monitoring
• Waiver Requests
• Tolerance Exemption Support
• Data Compensation
• Conventional Chemicals
• Antimicrobials

Services Offered

Flexible Specialty Consulting

• Product Development
• Regulatory planning and implementation
• Data Gap Analysis
• Endangered Species Act (ESA)
• Resistance Management Planning/Monitoring
• Data Planning & Management
• Early R&D Support
• Field, Greenhouse, & Lab Testing (GLP and Non-GLP)
• Technical Plan Development
• Risk Assessments
• Project Management
• Cross-functional Liaison
• Product Market Opportunity Evaluation

Services Offered

• Completion and submission of registration applications under the Canadian Fertilizers Act
• Microbial fertilizers
• Microbial identification data processing, generation of phylogenetic trees
• Processing of Bioinformatics data for risk assessment
• Toxicological hazard characterization for non-microbial ingredients
• Submission through My CFIA
• Risk assessment aids including, exposure modelling, plant uptake modelling, and dietary exposure modelling
• Canadian Agent services
• Completion and submission of applications to the U.S. EPA for registration of microbial pest control agents under FIFRA
• Building submission in CDX
• U.S. agent services
• Completion and submission of applications to the PMRA for registration of microbial pest control agents under the Canadian PCPA
• Build submissions in e-index builder for submission through e-PRS portal
• Canadian Agent services
• MPCA characterization completion (M2.7)
• Research Authorization completion
• Completion and Submission of organisms New Substance Notifications (NSNs) under the Canadian New Substances Notification Regulations (Organisms)
• Canadian Agent services
• Toxicological study review and monitoring
• Microbial ID as per Microbial Identification for Risk Assessment (MIFRA) Guidance
• Processing of Bioinformatics data for risk assessment
• Completion and Submission of bio-chemical and bio-polymer NSNs under the Canadian New Substances Notification Regulations (Chemicals and Polymers)
• Completion of Schedule 2 section on biochemicals/biopolymers
• Toxicological study review and monitoring
• TSCA-MCAN preparation
• Determination of obligations and eligibility for Tier I or Tier II exemption
• Building submission in CDX
• Acting as technical contact, providing regulatory follow up with U.S. EPA
• Processing of Bioinformatics data for risk assessment
• State level fertilizer registration/licensing
• Label review and harmonization
• Tonnage reporting and renewal support
• Hazard Communication services including SDS authoring and labelling support

Services Offered

Worldwide regulatory strategic consulting, project management, and registration services

• Data gap analysis and evaluation of data requirements
• Product evaluations and scoping to provide options for meeting business objectives
• Compilation and submission of dossiers in different countries and regions
• Efficacy assessment (comparison with conventional pesticides)
• Study management & monitoring
• Risk assessments (Ecological / Exposure Modeling)
• Biochemical classifications
• Tolerance and tolerance exemptions petitions
• Label compliance
• Amendments and notifications
• Data waiver requests
• State registrations
• Organic and other third-party certifications
• Liaison with authorities supporting pre and post-submissions
• TSCA Compliance

Services Offered

• US and Canadian Registrations
• Product Development
• Project Management

Services Offered

Comprehensive solutions for all your scientific and regulatory requirements

• • Biological Products Registrations
    • Biofertilizers
    • Biostimulants
    • Fermentation products
    • Inert ingredients/Fragrances
    • Microbials
    • Natural substances/plant extracts
    • Plant growth regulators
    • Semiochemicals
  • Regulatory Affairs and PMO
    • Asset and product categorization
    • Due diligence
    • Portfolio compliance and stewardship
  • Subject Matter Experts
    • Product chemistry
    • Toxicology
    • Residues
    • Environmental Fate
    • Ecotoxicology
    • Efficacy/Product Performance
    • Microbiology
    • Risk Assessment
  • Ad-hoc, on-demand flexibility
    • Sustainable registration strategies
    • Data analysis
    • Endangered Species and Endocrine Disruption Assessments
    • PFAS, FPAS, and Establishment reporting

Services Offered

• • Full Registration Services for Biopesticides, Antimicrobials, and Conventional Pesticides
  • Services for New Active Ingredients, Technical Registrations, and End Use Products
  • Tolerance Petitions and Exemptions
  • Data Development, Bridging, and Waivers for Toxicology and Ecotoxicity
  • Strategies for Data Call-In’s, Product Labels, 25(b) products
  • State Pesticide and Fertilizer Registration and Tonnage Reporting
  • Organic Certifications (OMRI, CDFA, WSDA, Ecocert, CERES)
  • Full US agent services
  • Canadian Agent service with PMRA & CFIA

Services Offered

• Pesticide and plant growth regulator registrations [e.g., new active ingredients (AIs), new sources of AIs, end-use products, “me-too” products, etc.].
• Tolerance (i.e., MRL) and tolerance exemption petitions (AIs and inert ingredients).
• Advice/counsel on pesticide products exempt from EPA registration [e.g., pesticide devices, FIFRA 25(b) products, etc.]
• Regulatory services for fertilizers (including bio-fertilizers), plant strengtheners, and soil amendments
• Study design, placement, and monitoring.
• EPA establishment registration, records maintenance, and reporting.
• Contract quality assurance (e.g., GLP facility, data, and report reviews).

Services Offered

• Full Registration Services for Biopesticides, Antimicrobials, and Conventional Pesticides
• Services for New Active Ingredients, Technical Registrations, and End Use Products
• Tolerance Petitions and Exemptions
• Data Development, Bridging, and Waivers for Toxicology and Ecotoxicity
• Strategies for Data Call-In’s, Product Labels, 25(b) products
• State Pesticide and Fertilizer Registration and Tonnage Reporting
• State Animal Feed and Pet Food Registration, Tonnage Reporting, Food Additive Petitions, GRAS Notifications
• Organic Certifications (OMRI, CDFA)
• Full US agent services

Services Offered

• U.S. and international biocontrols and registrations – biochemicals, microbials, antimicrobials, repellents, agricultural chemicals
• Biochemical classification
• Regulatory strategies • Toxicology and exposure evaluations
• Human and environmental risk assessment
• Data waiver justifications
• Data gap analysis
• Study placement
• Laboratory study monitoring
• New active ingredient and “me-too” registrations
• Label and advertising review and compliance
• Data compensation appraisals and negotiations
• Tolerance petitions and exemptions
• Amendments and notifications
• US and EU agent services

Services Offered

• Federal and State Registration & Maintenance Technical or End-use Products (Pesticide / Antimicrobial / Biopesticide / Biostimulant)
• Regulatory Guidance, Strategy, & Support
• Pre-registration Meetings and Consultation with EPA
• Data Compensation Evaluations
• Due Diligence for Company Mergers and Product Acquisitions
• Study Placement and Monitoring / Data Development
• Petitions to EPA for approval of inert ingredients or to set tolerances (MRL)
• Re-registration and Data Call-Ins (DCI)
• Label Compliance
• Product management
• Data Waiver Requests
• Organic Certification (OMRI, WSDA, NOP)
• Regulatory strategy and pathways
• Sales reporting to states

Services Offered through SynTech Research Group

• Bioefficacy (GEP) services
• International Registration Management
• Environmental chemistry (GLP) residue services
• Ecotoxicology services
• Seed services
• Food Processing
• Physical Chemistry and Formulation
• Program Management

Services Offered

• USDA National Organic Program Compliance

  • NOP Compliance Assessments
  • NOP Petition Preparation
  • Material Review Organization Application Assistance (e.g., OMRI, CDFA-OIM, WSDA)
  • Strategic Planning
  • Market Potential Analysis

  Product Development

  • Trial Design
  • 25(b) and Biopesticides
  • Literature Review
  • Efficacy Testing

  Federal and State Registrations

  • Pre-Registration Meetings
  • Compliance
  • Data Submission
  • Registration Maintenance and Renewals