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 - our team of 100+ senior consultants brings deep CMC expertise to move your science forward.
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.
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.
Senior consultants - PhDs, MBAs, scientists, and engineers spanning every CMC discipline.
Average years of industry experience across our consulting team.
Countries where our consultants have delivered successful outcomes for clients.
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 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.
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.
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.
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.
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.
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
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.
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Ian Smart
Managing Partner
Over 30 years in pharmaceutical and medical device consulting. Extensive knowledge across product development, manufacturing, and worldwide regulatory requirements.
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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.
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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.