Cosmetic & OTC CPG Consulting Services

Ethan Alden-Danforth, PhD — R&D, Formulation & Regulatory Advisory

I provide consulting services to cosmetic, OTC, and ingredient companies that need senior scientific and regulatory expertise without a full-time executive hire. Drawing on over 15 years of R&D and manufacturing leadership in the personal care industry — including my current role as Vice President of R&D for a cosmetic contract manufacturer — I help growing brands and ingredient suppliers solve technical, regulatory, and commercial challenges across the full product lifecycle.

My consulting work is distinct from my expert witness practice: rather than serving as a neutral analyst for litigation, I work directly in service of my client's business objectives, whether that means accelerating a product launch, navigating a regulatory challenge, building out a quality system, or developing scientifically defensible marketing claims.

Consulting Services

R&D Strategy & Formulation Development
Technical advisory on product concept development, formulation design, ingredient selection, prototype creation, and formulation optimization for cosmetic and OTC personal care products.

Regulatory Pathway Assessment
Analysis of cosmetic vs. OTC drug classification, MoCRA compliance requirements, labeling strategy, and regulatory pathway planning for new product development and market entry.

MoCRA Compliance
Practical guidance on Modernization of Cosmetics Regulation Act compliance including facility registration, product listing, safety substantiation file development, and responsible person obligations.

Claims Substantiation
Development and review of claims substantiation programs, testing strategy design, clinical and consumer use study oversight, and defensible claims copy review for technical marketing teams.

Scale-Up & Manufacturing Support
Technical support for scale-up from lab bench to pilot and commercial manufacturing, contract manufacturer selection and evaluation, and technology transfer.

Stability & Safety Testing Strategy
Design and review of stability protocols, shelf-life programs, safety testing strategies, and product safety file development in compliance with MoCRA and international standards.

Supplier Qualification & Quality Systems
Support for raw material supplier qualification programs, approved supplier lists, incoming quality control, and quality system development aligned with GMP expectations.

Ingredient Supplier Advisory
Technical and commercial advisory for cosmetic ingredient suppliers seeking to develop application data, substantiate ingredient claims, and support brand customers with formulation guidance.

Who I Work With

My consulting clients typically include emerging and mid-market cosmetic and personal care brands navigating product development or regulatory complexity; ingredient suppliers seeking technical support for customer-facing applications and claims; and contract manufacturers and private label operators requiring R&D or regulatory advisory support. I also work with investors and acquirers conducting technical due diligence on cosmetic and personal care businesses.

Qualifications

I hold a PhD in Organic Chemistry from Johns Hopkins University and currently serve as Vice President of R&D for a cosmetic contract manufacturer. I have spent over 15 years in senior R&D and manufacturing leadership roles in the personal care industry, with direct experience across formulation development, stability and safety testing, GMP manufacturing, regulatory compliance, supplier management, and technical marketing.

Related Services

FDA, MoCRA & GMP Compliance (Expert Witness)

False Advertising & Labeling (Expert Witness)

Contract Manufacturing (Expert Witness)

Product Liability (Expert Witness)

Contact

To discuss a consulting engagement, please use the form below or reach out directly.

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Shelburne, VT • Nationwide Engagements
Phone: 610-246-5600
LinkedIn: linkedin.com/in/ethan-ad-phd
JurisPro: jurispro.com/expert/ethan-alden-danforth-9364