Scientific excellence
Rigorous, phase-appropriate analytical science — method development, control strategy and characterisation grounded in deep large-molecule expertise.
Large molecule analytical CMC support
Analytical CMC science that gets your biologic submission-ready.
Elementary CMC is a specialist analytical CMC & QC consultancy for complex biologics, cell & gene therapy and novel modalities — from early development through to commercial.
20+
Years in analytical CMC & QC
IND·BLA·MAA
Submission readiness
Bio · CGT
Biologics & advanced therapeutics
How I work
Three commitments behind every engagement.
Strategic insight
CMC and regulatory strategy that anticipates what reviewers will ask — connecting the analytical package to your clinical and commercial goals.
Measurable impact
Hands-on delivery that de-risks programmes and moves submissions forward — clear deliverables, faster decisions, fewer surprises at filing.
Services
Specialist support across the analytical CMC lifecycle.
From first-in-human through to commercial filings — embedded support or targeted expert input where it matters most.
Analytical control strategy
Phase-appropriate control strategies, specification setting and comparability for biologics and advanced therapeutics.
Method development & validation
Development, qualification, validation and transfer of analytical methods across the product lifecycle.
QC strategy & oversight
QC frameworks, release and stability programmes, and data integrity for clinical and commercial supply.
CDMO selection & management
Selecting, onboarding and overseeing analytical CDMOs — keeping outsourced work on spec and on schedule.
20+Years in biologics CMC
About
Led by Laura Sherlock.
An analytical CMC & QC leader with more than 20 years bringing complex biologics and advanced therapeutics from early development through late-stage clinical and commercial — including late-stage monoclonal antibody programmes approaching BLA and a first-in-class gene-edited cell therapy.
Elementary CMC brings that senior, hands-on expertise to biotech and pharma teams who need analytical strategy and QC leadership they can trust.
Experience across leading biotech & pharma
PfizerJazz PharmaceuticalsProthenabit.bioCidara Therapeutics
In their words
What colleagues say.
A brilliant people and project manager — a senior member of the team who completely won me over with her clarity and rigour.
A highly skilled and motivated leader with a vast amount of experience in biologics, from analytics through to strategy.
Let's make your analytical package submission-ready.
Whether you need embedded CMC leadership or a focused expert review, let's talk about where your programme is heading.