Services

Regulatory Strategy

Our staff are experts in their respective fields and come from previous positions in the academic, chemical or contract research industries or government, giving us a unique perspective on regulatory requirements and scientific approaches.

We have extensive experience dealing with US, European, and global challenges across the chemical sector. Our strength has come not only from being able to adapt to industry trends, but by anticipating and applying new regulatory and scientific strategies to add value to client product development and registration pathways.

Experienced Support For:

  • Pre & Post Submission Liaison
  • Data Gap Analysis
  • Data Review & Evaluation
  • Study Placement & Monitoring
  • Dossier Preparation & Submission
  • Data Compensation
  • Regulatory Due Diligence
  • Litigation Support & Expert Witness Testimony
  • Task Force Representation & Administration
  • Literature Review

Regulatory Strategy Support in North America

EPA Regulatory Affairs

  • Regulatory strategies for agrochemicals, home and garden pesticides, mosquitocides, biopesticides and biostimulants, antimicrobial products, fertilizers, and consumer/industrial chemicals.
  • Agency liaison, representation, and negotiation, Environmental Protection Agency (EPA) registration package preparation and submission.
  • Consulting support for EPA’s Endocrine Disruptor Screening Program (EDSP) Tier 1 Test Orders and Tier 2 testing insight.

State Registration Management

  • First-time registration, renewals and fee payment support in all 50 states, District of Columbia, and US territories.
  • State submission package preparation (applications, labels, SDSs, technical data, reports, authorization letters, product summaries).

Data Development, Study Placement & Monitoring

  • Identification of required studies to support registration intent, and data gap analysis.
  • Placement and monitoring of tests at contract research organizations, review and interpretation of study results, assure compliance with Good Laboratory Practice (GLP) standards.

Technical Expertise

  • Expert guidance on product and residue chemistry, toxicology and endocrine disruptors, ecotoxicology, environmental fate, efficacy, endangered species, and economics.

Risk Assessment

  • Hazard identification, effects analysis, exposure assessment, and risk characterization.

Proposition 65 (Prop 65) & other State Regulations

  • Prevention and response to specific state regulations including California Proposition 65 and the state’s Safer Consumer Products/Green Chemistry Initiative.

Regulatory & Scientific Insights

  • Advice on emerging regulatory and scientific developments that may impact current and future registrations.
  • Tailored approaches to bring client products into compliance with new regulations.

Task Force Representation & Administration

  • Client representation on industry trade association consortia.
  • CSI staff serve in management, administrative and lead technical roles on chemical task forces.

Litigation Support & Expert Witness Testimony

  • Data compensation evaluation and expertise in supporting arbitration or settlement in lieu of litigation.
  • Comprehensive due diligence support to companies and investors prior to mergers, acquisitions, joint ventures and other activities.
  • In-depth expertise to support attorneys with case development.
  • Qualified trial depositions and expert witness testimony including support for data valuation, crop damage assessment, pesticide use or misuse and regulatory compliance.
  • Advice on emerging regulatory and scientific developments that may impact current and future litigation proceedings.

Literature Review

  • Evaluation of public domain scientific literature and data in support of registration.

Regulatory Strategy Support in Europe (EEA / UK)

EEA & UK Regulatory Affairs

  • Regulatory and environmental strategies for plant protection products including biopesticides, biocides, specialty and industrial chemicals, cosmetics, fertilisers and biostimulants, and animal health products.
  • Liaison with European regulatory agencies including European Chemical Agency (ECHA), European Food Safety Authority (EFSA) and the European Commission, in addition to UK and European Economic Area (EEA) (EU27 plus Iceland, Liechtenstein and Norway) national regulatory authorities.

Dossier Development & Submission

  • Preparation and submission of active substance dossiers for EEA and UK registrations.
  • Preparation and submission of product dossiers for EEA Member States (including zonal and mutual recognition) and the UK.

Data Development, Study Placement & Monitoring

  • Identification of required studies to support registration, data gap analysis, placement and monitoring of studies at contract research organizations, review and interpretation of study results, and Good Laboratory Practice (GLP)/Good Efficacy Practice (GEP) compliance consulting.

Technical Expertise

  • Expert guidance on product and residue chemistry, toxicology and endocrine disruptors, ecotoxicology, environmental fate, and efficacy.

Risk Assessment

  • Hazard identification, effects analysis, exposure assessment, and risk characterization.

Regulatory & Scientific Insights

  • Advice on emerging regulatory and scientific developments that may impact current and future registrations.
  • Recommend approaches to bring client products into compliance with new legislation.

Task Force Representation & Administration

  • Extensive experience in co-ordination of industry task forces.
  • Undertake both administrative and technical roles for task forces and consortia.

Litigation Support & Expert Witness Testimony

  • Services include data compensation evaluation and expertise in supporting arbitration or settlement in lieu of litigation.
  • Comprehensive due diligence support to companies and investors prior to mergers, acquisitions, joint ventures and other activities.
  • In-depth expertise to support attorneys with case development.
  • Qualified trial depositions and expert witness testimony including support for data valuation, crop damage assessment, pesticide use or misuse and regulatory compliance.
  • Advice on emerging regulatory and scientific developments that may impact current and future litigation proceedings.

Literature Review

  • Evaluation of public domain scientific literature and data to support client requests including in support of plant protection product registration dossiers in accordance with EFSA guidance.

Regulatory Strategy Experts

Robin Blake

Robin Blake

Principal Consultant

United Kingdom

Jennifer Stafford's Picture

Jennifer Stafford

Principal Consultant

Washington State

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Robin Blake
Principal Consultant

Expertise: Registration Dossier

Robin specialises in regulatory affairs strategy and registration dossier preparation for plant protection products, biocides, and fertilisers.

Robin  has over 20 years’ experience in the Crop Protection industry and consulting sector, having previously held various R&D leadership positions at Syngenta and Cyanamid Agriculture UK. He has a broad range of expertise encompassing laboratory and field trials for efficacy, pesticide resistance, and herbicide research, as well as terrestrial ecotoxicology where he was a Good Laboratory Practice (GLP) Study Director specialising in laboratory, semi-field, and field trials on a range of non-target arthropods, earthworms, honeybees and non-target plants. 

EDUCATION
Ph.D., Agricultural Ecology, University of Reading.
BSc (Hons), Applied Biology, University of Bath.

Jennifer Stafford
Principal Consultant

Expertise: Regulatory Compliance, Terrestrial Ecotoxicology, & Wildlife Science.

Jennifer leads CSI’s US Regulatory Affairs team, managing FIFRA and non-FIFRA (crop nutrition) product registrations, including those for biocides and biologicals. Jennifer participates in projects related to ecotoxicology, wildlife biology/ecology, GLP Compliance, database management, and USEPA guideline study management. Jennifer’s skills support regulatory staff, pesticide risk assessment, and endangered species assessments.

Jennifer has over 28 years of field research and laboratory ecotoxicology experience, including 20 years of Good Laboratory Practice (GLP) avian and wildlife study directorship and laboratory management. She has extensive experience interpreting the difference between animal behavior in the wild versus in captivity, and how these differences impact study design, husbandry practices and test results.  She has experience with developing and utilizing large data sets and is thoroughly familiar with EPA and OECD regulatory testing guidelines, Good Laboratory Practices guidelines, EPA and OECD guidance on pesticide risk assessment and EPA process for endangered species Biological Evaluation.

EDUCATION
M.S., Biology/Ecology, Utah State University.
B.S., Environmental Biology, Grand Canyon University.