CMC Consulting & Product Management

From molecule to market.

We partner with pharmaceutical and biotech companies to navigate every stage of the product lifecycle — from early-stage development through regulatory approval and commercial launch.

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Pre-Clinical

Discovery

Early development phase

Phase I

First-in-human

Safety assessment

Phase II

Efficacy

Dosing & response

Phase III

Pivotal Trials

Confirmatory studies

Launch

Market

Regulatory approval

Growth

Scale

Commercial scale-up

Our Services

End-to-end CMC expertise tailored to your stage and scale.

science

Drug Substance

Small and large molecule biologics development, from process design through commercial validation.

biotech

Drug Product

Formulation development for injectables, solids, and inhalations with deep tech-transfer expertise.

monitoring

Analytical

Method development, validation, and stability program design from discovery through post-approval.

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Regulatory Affairs

Global strategy across FDA, EMA, MHRA, and 95+ countries.

precision_manufacturing

CDMO Selection

End-to-end contract manufacturing oversight and negotiation.

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Supply Chain

Trade compliance and logistics across global markets.

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Quality Mgt

Audit-ready systems from early R&D through commercial supply.

Built for the long run

A team of experts who've been where your molecule needs to go.

Our consultants are former industry leaders who have developed, registered, and launched products across the globe.

100+

Senior consultants spanning every CMC discipline.

25+

Average years of industry experience across our team.

65+

Countries where we have delivered successful outcomes.

450+

Projects completed from pre-clinical to commercial launch.

Proven Impact

Real results across the product lifecycle.

From monoclonal antibodies to global partnerships, see our expertise in practice.

Biologics at Speed

mAb to commercial in 24 months

Led the entire CMC program for a novel therapy, coordinating seven CDMOs across drug substance and fill/finish.

Quality Management

Phase-appropriate GxP-compliant QMS

Designed and implemented right-sized quality systems from early R&D through commercial supply for global clients.

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We partnered with Verta to take our mAb from pilot batch to commercial readiness in just over 24 months. Incredible technical expertise combined with business acumen makes them the ideal CMC partner.

Tim Morris

COO/CFO, BioTech Company

Leadership

Led by decades of industry experience.

Nick Davies

Managing Partner

Over 30 years in pharmaceutical and biotechnology, responsible for the global supply of billions in product.

Ian Smart

Managing Partner

Over 30 years in pharmaceutical and medical device consulting with worldwide regulatory expertise.

Beth Lindsey

Partner

Over 30 years in business development and supply chain optimization with deep CDMO knowledge.

Common questions

What types of companies does Verta work with? expand_more

We serve pharmaceutical, biotech, and medical device companies of all sizes — from early-stage startups bringing their first molecule to clinic, through to large multinationals optimizing global supply networks.

How does Verta's engagement model work? expand_more

We match you with consultants who have specific expertise relevant to your project. Engagements are flexible — from short-term advisory to long-term embedded partnerships.

What regions does Verta operate in? expand_more

Headquartered in Raleigh, NC with offices in the UK and China. Our consultants have delivered successful outcomes in over 65 countries.

Ready to move your molecule forward?

Whether you are navigating a complex CMC challenge or planning your next milestone, start a conversation with our team today.