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Formulation and analytical development
Our drug product development experts prepare small molecule formulations for pre-clinical and clinical studies with phase-appropriate quality. We integrate analytical method development, formulation R&D, and GMP manufacturing to design practical, data-driven strategies that optimise the solubility, stability, and bioavailability of your molecule.
The result is material that performs, documentation that’s submission ready and a smooth path toward IND filing.
Early formulation screening and pre-formulation support:
- Solubility, stability and excipient compatibility studies
- Development of phase-appropriate formulations (e.g., solutions, suspensions, capsules and tablets)
- Drug product manufacturing for clinical trial supply (Phase I, II and III)
- Analytical method development, implementation, qualification, and validation
- Physicochemical characterization and impurity profiling
- Integration with drug substance development and manufacturing
- Dedicated support for preparation of IND/IMPD documentation
Early involvement of our formulation and analytical experts reduces risk, improves material performance, and keeps your molecule on track to clinical evaluation
Expertise that drives formulations
Integrated science, faster answers
Formulation and analytical teams work side by side, so potential development issues with solubility, stability, or bioavailability are identified and solved early – not discovered at IND.
Continuity from discovery to development
Early involvement of CMC specialists connects chemistry, analysis and formulation. It reduces risk and keeps timelines tight between candidate nomination and IND.
Flexible, phase-appropriate support
Whether you need a stand-alone preclinical formulation result or a complete IND-enabling package, we adjust our approach to your molecule, data needs and development pace.
Thinking ahead in pre-clinical drug development
Our formulation and analytical development are fully integrated with Symeres’ broader preclinical CMC capabilities. This connection links drug substance development and manufacturing, ADME-tox and solid-state chemistry to keep data and decisions aligned from candidate selection to clinical supply.
We provide:
- GMP manufacturing services for tox studies and clinical supply
- Process development and IND support
- High-throughput solid-state screening and polymorphic form profiling
This integration reduces handoffs, shortens timelines, and ensures material and documentation are ready and appropriate for regulatory submission.
What do our partners say?
“If the compound can be made, Symeres will undoubtedly find out a good way to make it.”
Dooyoung Jung, CEO
Pinotbio
“The team is making short work of these targets, so we will have to start thinking of some additional targets!”
Director
Biotech
“Through our dedicated FTE resource at Symeres we have achieved remarkable results, not only by developing a new “aspirational” synthetic route but also by significantly improving the current one to deliver a sustainable route for commercial production and giving us two options for late development.”
Associate Director
Large pharma, Europe
“The progression was really phenomenal. I am truly impressed. There is a world of difference between you and other CROs.”
Start-up Founder
Biotech
“I would like to extend my thanks for the excellent work Symeres has done in synthesizing the API for Part 1 of our project. Your communication throughout the process was outstanding, and the sense of urgency with which you operated allowed us to complete this phase promptly and efficiently.”
Leader
Large biotech
“A sign that things are going well - we keep coming to you. We’ve given Symeres five or six different projects already. That’s almost unheard of for us.“
Senior Director, Manufacturing
Top 10 global pharma
“We’ve been with them…over 10 years. The cost, the flexibility - the value is just so strong. That’s why we’ve stuck with them.”
Senior Director, CMC
Biotech
“They’ve always met or exceeded my expectations - that’s why I continue to come back, company after company, year after year.”
Allen Horhota, Vice-President Platform & Delivery
Seamless Therapeutics
“We are developing the most complex molecule that is built at this time in the world…We work with a lot of CROs, also chemistry CROs, and so far Symeres has done the best job with respect to transparency and also to troubleshoot the problems and find a solution. Over the years we have been really impressed with the work that Symeres has done.”
Founder
Biotech
Your transatlantic discovery and development partner
Symeres supports small-molecule programs from discovery through IND and beyond with openness, agility and scientific depth. Our connected teams in Europe and North America provide medicinal chemistry, computational chemistry, synthetic chemistry, and specialty chemistry services integrated with biology, ADME-tox, and CMC development.
We share data transparently, adapt quickly to new results, and stay accountable from first experiments to IND, to keep your progress clear, connected and continuous. Projects can run as standalone studies or as coordinated, multi-disciplinary programs.
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Speak with our pre-clinical formulation and analytical experts
Speak with our pre-clinical formulation and analytical experts.