Pharmaceutical research laboratory with scientific equipment for CMC and drug development

CMC Consulting & Product Management Our Services

From molecule to market.

Q: What types of companies does Verta work with?

Verta serves pharmaceutical, biotech, and medical device companies of all sizes — from early-stage startups bringing their first molecule to clinic through large multinationals optimizing global supply networks. Verta also provides CMC expertise to government agencies including the Department of Defense and BARDA.

Q: How does Verta's engagement model work?

Verta matches clients with consultants who have expertise relevant to each project. Engagements are flexible — from short-term advisory on a specific challenge to long-term embedded partnerships where consultants work alongside the client team.

Q: What regions does Verta operate in?

Verta is headquartered in Raleigh, North Carolina with a UK office in Cardiff. Consultants have delivered successful outcomes in over 65 countries, with deep regulatory expertise across FDA, EMA, MHRA, WHO, and agencies worldwide.

Q: Can Verta help select and manage CDMOs?

Yes. CDMO selection and management is a core Verta strength — from defining selection criteria and evaluating RFPs through contract negotiation, tech transfer oversight, and ongoing performance management.

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 - our team of 100+ senior consultants brings deep CMC expertise to move your science forward.

Start a conversation Explore services

Pre-Clinical

Discovery & development

Phase I

First-in-human

Phase II

Efficacy & dosing

Phase III

Pivotal trials

Launch

Regulatory & market

Growth

Commercial scale

Trusted by companies around the globe

Our Services

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

Whether you're advancing a first-in-human candidate or scaling for commercial supply, our consultants bring decades of hands-on experience across every CMC discipline.

Drug Substance Development

Small molecule and large molecule biologics development, from process design through commercial validation. Monoclonal antibodies, cell & gene therapy, and complex chemical synthesis.

Drug Product Development

Formulation development for injectables, liquids, topicals, inhalations, and solid dosage forms. Scale-up, tech transfer, and process qualification across all product types.

Analytical

Method development, validation, and transfer. Stability program design, impurity assessment, and in-vitro testing expertise from drug discovery through post-approval.

Regulatory Affairs

Global regulatory strategy and submission management. INDs, NDAs, BLAs, MAAs, and post-approval variations across FDA, EMA, MHRA, WHO, and 95+ countries.

CDMO Selection & Management

End-to-end contract manufacturing oversight. Supplier evaluation, contract negotiation, tech transfer, and ongoing performance management.

Supply Chain & Logistics

Global trade compliance, distribution strategy, and operational support. We've optimized supply chains spanning 151 markets and delivered $1.8B in annual savings.

Packaging & Artwork

Primary and secondary package design, regulatory artwork, serialization, and barcode systems. Over 100 new product launches supported.

Quality Management

Quality systems design and remediation, GMP/GLP/GDP audits, regulatory inspection support, and supplier quality management.

Expert Witness Support

Case document review, subject matter expert reports, deposition preparation, and trial testimony from seasoned industry professionals.

Verta Life Sciences CMC consultants in a strategic planning meeting reviewing global business performance

Built for the long run

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

Our consultants aren't just advisors - they're former industry leaders from companies like GSK, Pfizer, and Sanofi. They've developed, registered, and launched products across the globe. That experience is now working for you.

100+

Senior consultants - PhDs, MBAs, scientists, and engineers spanning every CMC discipline.

25+

Average years of industry experience across our consulting team.

65+

Countries where our consultants have delivered successful outcomes for clients.

450+

Projects completed - from pre-clinical development through commercial launch and growth.

Proven Impact

Real results across the product lifecycle.

From accelerating a monoclonal antibody to commercial readiness in 24 months to helping US biotech clients acquire and develop Chinese-originated assets - here's what our expertise looks like in practice.

Biologics drug vial in gloved hand with global manufacturing analytics for monoclonal antibody programs

Biologics at Speed

mAb to Commercial in 24 Months

Led the entire CMC program for a potential monoclonal antibody COVID treatment. Rapidly scaled up and managed 7 CDMOs across drug substance, drug product fill/finish, and clinical packaging - simultaneously.

GMP quality control scientist in nitrile gloves inspecting a drug product vial

Quality Management

Phase-appropriate GxP-compliant QMS

Verta helps clients develop, implement, and continually evolve right-sized quality systems from early R&D through clinical development and into commercial supply.

Magnifying glass over China on a world map representing pharmaceutical due diligence and CMC review in Asia

China Due Diligence

From China partnerships to Western clinical development

Verta has supported four such partnerships, helping US biotech and pharma clients acquire Chinese-developed assets and navigate the scientific, regulatory, and operational complexities of bringing these molecules into U.S. and EU clinical development.

Technician in cleanroom PPE inside a pharmaceutical CDMO manufacturing facility

Small Molecule Launch

Clinical-stage therapy launch support

Supported manufacturing sourcing, CDMO evaluation, drug product qualification across three CDMOs, contractual guidance, and quality audit oversight for a clinical-stage small molecule program moving toward commercialization.

Pharmaceutical quality inspector in blue gloves reviewing oral solid dose tablets on a production line

Small Molecule, OSD, Oncology

CMC support from pre-clinical through clinical and IP protection

Led CMC support for a pre-clinical small-molecule oncology program, including product development, regulatory filings, and QMS. Improved poor solubility with an SSD process, secured new IP, reformulated the product into a direct-compression tablet, and later strengthened IP further through prodrug development.

Gloved technician preparing topical drug product formulation in a pharmaceutical manufacturing environment

Small Molecule, Topical, Inflammatory

Phase 1 through commercial US supply and China Expansion

Verta supported CMC, DS and CDMO sourcing, scale-up oversight, analytical work, regulatory filings, and QMS from Phase 1 through NDA approval and commercial US supply, then supported the CNDA filing for a new China client.

What our clients are saying

We measure our success by the outcomes we create for our clients - products registered, launches executed, and partnerships that last.

"
I would highly recommend Verta Life Sciences for all of your CMC needs. 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 Verta the ideal CMC partner.

Tim Morris

COO/CFO, BioTech Company

"
Overall, I highly recommend Verta to anyone in need of top-quality CMC consulting services. They have a team of highly skilled professionals who are dedicated to helping their clients succeed. I look forward to working with them again in the future.

Dr Cameron Durrant

CEO, BioTech Company

"
We have had the pleasure of working with Verta Life Sciences for over 5 years now. All the consultants that we have worked with are professional, knowledgeable, and dedicated to ensuring the success of all our projects.

COO

Pharmaceutical Company

Leadership

Led by decades of industry experience.

Meet all our consultants

Nick Davies

Managing Partner

Over 30 years in pharmaceutical and biotechnology. Responsible for the annual supply of over $5 billion worth of pharmaceutical products globally.

Ian Smart

Managing Partner

Over 30 years in pharmaceutical and medical device consulting. Extensive knowledge across product development, manufacturing, and worldwide regulatory requirements.

Beth Lindsey

Partner

Over 30 years in business development, product launch, and supply chain optimization. Deep knowledge of contract manufacturing with a track record of matching the right manufacturer to each client.

Common questions

What types of companies does Verta work with?

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 their global supply networks. We also provide CMC expertise to government agencies including the Department of Defense and BARDA.

How does Verta's engagement model work?

We match you with consultants who have specific expertise relevant to your project. Engagements are flexible - from short-term advisory on a specific challenge to long-term embedded partnerships where our consultants work alongside your team.

What regions does Verta operate in?

We're headquartered in Raleigh, North Carolina with a UK office in Cardiff. Our consultants have delivered successful outcomes in over 65 countries, with deep regulatory expertise across FDA, EMA, MHRA, WHO, and agencies worldwide.

Can Verta help select and manage our CDMOs?

Absolutely. CDMO selection and management is one of our core strengths. We handle the entire process - from defining selection criteria and evaluating RFPs, through contract negotiation, tech transfer oversight, and ongoing performance management.

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.