From Science to Submission — Your Partner in CMC, R&D & Regulatory Affairs
CMC WISE– Small Molecule R&D and Regulatory Services
We help pharmaceutical & biotech innovators translate small-molecule science into global market-ready products.
Who we are?
CMC Wise is a UK-based small-molecule R&D and regulatory platform specialising in formulation, analytical and dossier-ready CMC deliverables. We design experiments around each molecule’s unique profile, run data-forward stability and analytics, and author submission-ready Module 3 packages in parallel with lab work. Our teams are senior-led, audit-ready, and deeply practiced in EMA, MHRA and FDA routes — so teams bring clear scientific reasoning and regulatory foresight from day zero to approval and beyond.
R&D
Formulation innovation for sterile injectables, ophthalmics, oral solids and oral liquids. Data-driven design, DoE, and CMC-aligned output.
Regulatory Affairs
EMA / MHRA / FDA strategy, 505(b)(2) planning, lifecycle management, labeling and dossier assembly. Authoring and submission support across regions.
Our Difference
Science-Driven
We design around the molecule and the data, not around templates
Integrated Workflow
Formulation and regulatory speak to each other from day zero
Senior-Led
Access to decision-makers, not layers of account management
Transparent Milestones
Defined steps, documented data, audit-friendly output
Formulation Science, Reimagined for Small Molecules.
Every molecule behaves differently. We build data-driven formulations tuned to your molecule and CMC timeline.
Science that adapts to the molecule.
We start with solubility, ionisation, degradation, polymorph behaviour. We model risks before we run them. We design before we test, predict before we scale.
Where chemistry meets data and manufacturing reality.
Pharmaceutics
Translate molecular properties into dosage form behavior.
Analytical Chemistry
Define purity, potency, and stability with validated methods.
Bioinformatics /Biostats
Predict excipient compatibility and release kinetics via DoE.
Regulatory Science
Build Module 3-ready data packages in parallel with lab work.
Formulating for Function.
Sterile Injectables
Depot, RTU, nanosuspensions, emulsions. Focus on particle size, rheology, solvent balance.
Ophthalmic
Aqueous & suspension systems. Viscosity, preservative balance, sterility built in early.
Oral Solids
IR / MR tablets, MUPS, pellets. Low-solubility actives, polymorph control, release matrices.
Oral Liquids
Palatable solutions & suspensions. Taste masking, dose uniformity, patient usability.
Agile development. Transparent milestones.
Fee-for-service (you own the data) and co-development (shared risk / shared upside). Both run on milestone-driven execution and audit-ready documentation.
1. Pre-formulation
Solubility, salt/polymorph screening, risk map.
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2. Formulation Design
DoE, excipient matrix, prototype build.
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3. Analytics & Stability
Method validation, ICH stability, release profile.
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4. Scale-Up & Transfer
Exhibit batch, tech transfer, CMC package.
Tools that turn data into design.
| Capability | Focus |
|---|---|
| Pre-Formulation | Solubility & pKa profiling, polymorph screening, degradation kinetics |
| Formulation Design | QbD DoE, excipient compatibility, stability prediction |
| Analytical Sciences | HPLC/GC/LC-MS method development & validation |
| Stability Programs | ICH-compliant accelerated / photo-stability studies |
| Scale-Up | Process optimisation, aseptic fill simulation, exhibit batch |
| Documentation | CMC data packages, tech transfer reports, audit trail |
We build formulations that endure — scientifically and regulatorily.
“We don’t just develop formulations. We build the data packages that make them real.”
Start a Discussion
Short confidentiality reassurance. Invite them to share target molecule, dosage form, timeline pressure.
Global Strategy. Local Compliance. Submission-Ready Execution.
We align science, CMC data, and submission logic across EMA, MHRA, and FDA.
Regulation as a continuum of science.
We build the submission story while the science is still being generated, ensuring every number in the dossier is anchored and defensible.
Cross-agency expertise.
EMA
CP, DCP, MRP, NP. Scientific Advice. Module 1–5 authoring. Variations & renewals across member states.
MHRA (UK)
National procedure, Reliance pathway, accelerated / rolling review. Ongoing lifecycle management, PSURs, variations.
FDA (US)
505(b)(1), 505(b)(2), ANDA. Meeting briefing books, IND/NDA assembly, ESG submission. IR / DRL / CRL responses, SPL & labelling.
Every module tells a story.
We maintain traceability from analytical tables to clinical summaries. Clear logic, consistent data, regulator confidence.
Compliance beyond approval.
We manage variations, renewals, labelling updates, PSURs. Change control systems that scale across regions.
Pathway strategy with foresight.
505(b)(2), hybrid, national vs centralised — we model pathway, cost, and data expectations before you commit budget.
From lab bench to Module 3.
Regulatory and R&D share the same spine here. The formulation rationale, stability story, and manufacturing narrative are built to be dossier-ready.
Agile expertise. Global perspective.
Direct access to senior people. Transparent scopes. No big-consultancy fog.
Plan Your Next Submission
We handle submission planning with full confidentiality and clear regulatory reasoning. Let’s map your pathway across MHRA, EMA or FDA with confidence.
Science, Compliance, and Clarity — That’s Our DNA.
CMC Wise was created to close the persistent gap between strong formulation science and real-world regulatory expectations. Too many programs fail not because the science is weak, but because the CMC narrative is unclear, incomplete, or not aligned with agency thinking. We set out to change that. Our approach brings formulation design, analytical rigor, and regulatory reasoning together from day one — led directly by senior scientists and regulatory strategists. Every dataset, every decision, and every document is built to withstand technical scrutiny and to move confidently through MHRA, EMA, and FDA pathways. Science, compliance, and clarity aren’t slogans for us — they’re our operating system.
Integrity
No theatre. Just honest data and clear narrative.
Precision
Our work stands in audits and agency review.
Collaboration
We act like part of your internal team, not an external supplier.
Agility
Senior decision-making without corporate delay.
Global Network
We operate from London with CRO/CDMO partners across EU, UK, US and Asia, enabling exhibit batches, regional stability programs and tech transfer. Tell us your target markets and timelines — we’ll align the network
Let’s Talk.
Ready to discuss your next molecule or submission? We work with companies building small-molecule assets across sterile injectables, ophthalmics, oral solids, and oral liquids — and we support submissions across EMA, MHRA, and FDA.
CMC Wise Ltd
63-66 Hatton Garden, Fifth Floor, Suite 23
London EC1N 8LE, United Kingdom
info@cmcwise.com