Product Stewardship
Bring safe, compliant products to market and keep them there with science-based strategies that protect both human health and the environment.
Product stewardship challenges can derail launches, trigger costly recalls, and damage your brand reputation. As industry-leading scientists with deep technical expertise across toxicology, chemistry, and environmental science, we provide clear strategies that get your products to market faster and keep them there successfully.
Product Stewardship Experts
Ernest Fung, Ph.D., DABT, ERT Principal, Toxicology, Health, and Ecological Sciences
Kristian Fried, Ph.D., Dr. rer. nat., DABT, ERT Senior Consultant
Morgan Willming, Ph.D., DABT Consultant
Claire M. Hamaji, MPH Consultant
Relevant Experience
Sunscreen Safety Requirements
Assessing Pesticide Risk Using Mesocosm Studies
Peer-Reviewed Scientific Rigor for Setting Occupational Exposure Standards
Environmental Risk Assessment for a New Drug Application of a Novel Active Pharmaceutical Ingredient
Product Vulnerability and Business Risks of Consumer Product
Developing a Screening Environmental Assessment Framework for Fragrances
In today’s dynamic market, successfully launching and maintaining a product requires more than just meeting consumer demands.
We specialize in navigating the complexities of the product life cycle, ensuring compliance with state, federal, and international regulations, occupational health and safety requirements, and sustainability standards at every stage.
Regulatory Compliance
Navigate complex regulatory landscapes with confidence and avoid costly delays.
We work directly with FDA, EPA, ECHA, and other global agencies to ensure your products meet all requirements before launch. Our strategic approach transforms regulatory hurdles into competitive advantages.
Key Capabilities:
- Streamline approvals through proven regulatory pathways and strategic submissions
- Defend existing products against regulatory challenges and maintain market access
- Navigate REACH, Proposition 65, MoCRA, and international compliance requirements seamlessly
- Design custom studies that satisfy regulatory requirements cost-effectively
Environmental Safety
Protect your brand from environmental liability while meeting stakeholder expectations.
We assess down-the-drain impacts, environmental fate, and ecological risks to ensure your products enhance rather than harm your sustainability reputation.
Specialized Services:
- Efficient environmental risk screening tools for large product portfolios
- Predicted no-effect concentration (PNEC) modeling and exposure assessments
- Strategic environmental testing programs that ensure compliance efficiently
- Regulatory-grade environmental safety documentation for global markets
Environmental Fate
Understand exactly where your products go and how they behave in the environment.
Our customized testing approaches and modeling predict environmental behavior, helping you anticipate and address potential concerns before they become problems.
Core Solutions:
- Biodegradation and bioaccumulation studies designed for regulatory acceptance
- Surface water occurrence modeling and environmental concentration predictions
- Custom benchtop testing approaches tailored to your product properties
- Strategic data packages that close environmental safety loops efficiently
Product Safety Assessments
Ensure product safety while protecting your business from recalls and liability.
We deliver safety assessments that integrate seamlessly into your systems and support both regulatory submissions and marketing claims with scientific rigor.
Safety Solutions:
- Margin of safety calculations and comprehensive risk assessments
- Occupational, consumer, and patient health safety substantiation
- Biocompatibility assessments for medical devices and specialized products
- Bespoke safety documentation that meets global regulatory standards
Product Vulnerability Assessments
Anticipate future risks and protect your market position before challenges arise.
We identify business risks from evolving regulations, retailer policies, and public sentiment, enabling strategic investments that keep your products competitive.
Risk Mitigation:
- Future-focused regulatory landscape analysis and strategic planning
- Retailer sustainability policy compliance and stakeholder engagement strategies
- Ingredient defense strategies and research prioritization guidance
- Business risk assessment tools that inform R&D investments strategically
Litigation Support and Product Defense
Defend your products with credible scientific evidence when litigation threatens your market position.
Our experienced expert witnesses provide compelling testimony and rigorous technical analysis that withstands cross-examination and supports successful case outcomes.
Expert Services:
- Expert witness testimony with proven track records in depositions and trials
- Detailed technical reports and affidavits that present defensible scientific arguments
- Case strategy development grounded in toxicology, chemistry, and environmental science
- Rebuttal analysis and critique of opposing expert opinions and methodologies
Our Partnerships
FAQs
The earlier, the better. We’re most valuable during product design and development phases, where strategic decisions can prevent costly regulatory delays and environmental concerns. However, we also help when existing products need to navigate new regulations and be defended against emerging challenges.
We operate as a single profit center with unfettered collaboration between chemists, toxicologists, engineers, and business strategists. This means you get integrated multidisciplinary solutions rather than siloed expertise. Our team includes consultants with direct experience in industry and government regulatory agencies, providing insider perspectives on what actually works in practice.
Our team has direct experience working with FDA, EPA, ECHA, and other global agencies. We design studies using proven methodologies and maintain ongoing relationships with regulatory bodies to ensure our approaches meet current and evolving requirements.
Yes. We’ve developed proprietary screening tools that rapidly assess large volumes of products and ingredients for environmental and safety risks, allowing you to prioritize resources and focus detailed assessments where they’re needed most.
We provide holistic assessments from raw material sourcing through disposal, addressing supply chain impurities, manufacturing releases, consumer use, and end-of-life environmental impacts. This comprehensive approach ensures no critical risks are overlooked.