Design • Develop • Transfer

About Middlesex Consulting Group

Middlesex Consulting Group partners with organizations developing complex diagnostic and therapeutic assets, bringing technical depth, operational acumen, and intellectual property and licensing expertise to move programs through regulatory review, clinical testing, and commercial launch. With more than 20 years bridging the gap between the research laboratory and commercial launch, our team has advanced products from single concept startups through multiproduct, multinational portfolios, working across virtually every major market. That experience extends into patent portfolio management, prior art analyses, licensing strategy, and regulatory support, giving clients a combination of scientific, operational, and legal and regulatory fluency that's hard to find in one place. We integrate directly within client teams throughout the development lifecycle, from early discovery to commercial launch. We believe development is a team sport and are heavily invested in our clients' success.

Founder & Principal

Colin D. White, Ph.D.

Colin White, Ph.D., is a scientist by training, engineer by trade, and a product strategist by track record, who has brought complex diagnostic and therapeutic assets from concept to commercialization at both clinical and commercial stage companies. For more than 20 years, he has bridged the gap between the research laboratory and commercial launch by partnering alongside and embedding deeply within teams to address complex challenges in product development, manufacturing, regulatory affairs, and clinical research, and bring the next generation of therapeutics to market.

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Ph.D. in Molecular and Cellular Biology from the University of Edinburgh

Research experience at Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, and Harvard Medical School

Expertise in Development Strategy, Technology Transfer, Intellectual Property and Licensing, Manufacturing, and Commercialization

How We Work

We don't advise from a distance. Rather, we believe that product development is a team sport. We embed directly within our clients’ teams, working alongside scientists, engineers, and program leads. Our approach typically takes one of two forms. Where a team has strong capability but needs additional strategic direction or bandwidth, we strengthen what's already there. Where a capability gap exists entirely, we step in to provide it directly, building the function rather than pointing toward it.

What We Can Do

With more than 20 years bridging the gap between the research laboratory and commercial launch, we have honed distinct capabilities that advance the development of both diagnostic and therapeutic assets.

Product Strategy & Design

User Needs Collection, and Product and Packaging Design
Human Factors Testing
Intellectual Property and Licensing Strategy

Development & Validation

Product and Process Development and Validation
Verification and Validation Testing
Biocompatibility Testing (Including Extractables & Leachables Studies)
Terminal Sterilization Cycle Design and Validation
Analytical Method Development and Validation

Quality Assurance & Risk Management

Design Control and Quality by Design
Product and Process Risk Analysis and Management
Root Cause Analyses
Audit Preparation

Manufacturing & Technology Transfer

CDMO Sourcing and Selection
Technology Transfer and Comparability Strategy Development
Life Cycle Management

Why Middlesex?

Technical Depth

Deep life sciences expertise rooted in product development background.

Operational Acumen

Hands-on approach that turns strategy into tangible, measurable, real-world results.

Intellectual Property and Licensing Background

Patent prosecution strategy experience, together with deep technical acumen and licensing experience, offers a unique value proposition in this space.