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

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.

EEA & UK Regulatory Affairs

  • Regulatory and environmental strategies for plant protection products including biopesticides, biocides, specialty & 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 & 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's Picture

Robin Blake

Principal Consultant

Scotland

Melinda Bowman's Picture

Melinda Bowman

Principal Consultant

California

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Robin Blake
Principal Consultant

Expertise: Registration Dossier

Robin specializes in registration dossier preparation and plant protection product, biocide, and fertiliser risk assessments.

Robin previously worked for Cyanamid Agriculture UK and Syngenta for 12 years, conducting field trial, entomology, pesticide resistance, and herbicide research. He has extensive experience as a Good Laboratory Practice (GLP) Study Director in Terrestrial Ecotoxicology, specialising in laboratory, semi-field, and field trials on a range of non-target arthropods, earthworms, honeybees and non-target plants. His work often culminated in regulatory risk assessments in support of plant protection products.

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

Melinda Bowman
Principal Consultant

Expertise: Regulatory Affairs

Melinda has extensive experience in FIFRA regulatory compliance and product registration of agrochemicals and consumer products within the United States and Canada. She provides support and strategy for global pesticide registration actions, including support and coordination of the establishment of international MRLs, FDA 510(k) submissions and hand sanitizer listings.  She specializes in following new developments in regulatory compliance project management for EPA and FDA regulated products as well as agrochemical and pharmaceutical product development. 

EDUCATION
BS, Chemistry, San Francisco State University.