Home / Drug development / CMC and beyond / Clinical formulation development and analytical services
Clinical formulation development and analytical services
We provide formulation development services and analytical expertise that keep your programs moving from preclinical studies to Phase III.
Our teams design fit-for-purpose clinical formulations, validate analytical methods and oversee drug product formulation and GMP manufacturing. Rapid screening and troubleshooting workflows shorten development timelines, while close collaboration across formulation, analytical, and chemistry groups maintains data consistency and reduces transfer risk.
Complete, regulatory-aligned documentation – including analytical packages, formulation data, and stability reports – supports IND and IMPD filings, giving you the clarity and confidence to progress each phase without delay.
Key capabilities include:
- Formulation development – Phase-appropriate strategies that enhance solubility, stability and bioavailability – accelerating candidate readiness from preclinical to Phase III.
- Analytical development – Robust analytical methods and validated workflows that deliver reliable data, regulatory confidence, and smoother regulatory submissions.
- Drug product manufacturing – Scalable, phase-appropriate drug product manufacturing – consistent quality, dependable supply and continuity from first formulation to clinical delivery
How we work:
- Fit-for-purpose workflows – Rapid screening and troubleshooting workflows shorten development timelines, delivering data quickly.
- Cross-functional continuity – Formulation, analytical, and chemistry groups work together, reducing tech transfer risk and ensuring data consistency.
- Regulatory-aligned documentation – Complete CMC support, including analytical packages, formulation data and stability reports suitable for IND and IMPD filings.
Related services
Formulation and analytical development expertise
20+ years of expertise
Decades of formulation and analytical experience delivering regulatory-ready data and confidence in every IND/IMPD submission.
Integrated CMC services
Unified chemistry, formulation and analytics that reduce transfer risk, maintain data consistency and keep your development timelines on track.
Rapid
turnaround
High-throughput workflows provide fast, dependable formulation and solid-state insights, so your program advances without delay or disruption.
Integrated chemistry, manufacturing and controls
Our integrated CMC services connect early design with clinical delivery.
Non-GMP API for toxicology studies and GMP manufacturing up to 1,000 L provide reliable, phase-appropriate supply.
By bridging drug substance and drug product, we align CMC activities from lab to clinic to reduce risk, shorten timelines and support confident IND submission for early success.
What do our partners say?
“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
“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
“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
“The progression was really phenomenal. I am truly impressed. There is a world of difference between you and other CROs.”
Start-up Founder
Biotech
“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
“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
“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
Your discovery and development partner
Symeres supports small-molecule programs through formulation, analytical development, and clinical manufacturing with the same openness and precision that define our discovery work.
Our transatlantic teams coordinate closely to keep CMC data aligned, timelines predictable, and supply reliable from tox studies to Phase III. Whether as a standalone service or integrated partnership, you gain continuity, compliance confidence and clarity at every step toward regulatory success.
Resources we think you'll love
Blog
CDMO red flags you can’t ignore: Regulatory shortfalls and misalignment
Whitepaper
5 CDMO red flags you can’t ignore: A guide for biotechs and pharma
Blog
CDMO red flags you can’t ignore: Underestimating technology transfer complexity
Blog
O.N.E Symeres: A practical approach to real-world drug development
Blog
CDMO red flags you can’t ignore: Undefined or shifting project scope
Whitepaper
Accelerating chemical innovation: Unveiling Symeres’ parallel chemistry
Webinar | On-demand
From racemic to pure the art and science of enantiomer separation
Whitepaper
IND & IMPD enabling developability roadmap
Whitepaper
Innovations in unnatural amino acids: Advancing functional diversity and applications
Whitepaper
Leveraging copper-catalyzed ullmann-type cross-coupling reactions in PR&D
Whitepaper
Managing nitrosamines in the pharmaceutical industry: A comprehensive approach
Whitepaper
Optimizing solid-state properties and enhancing API bioavailability through physicochemical prediction
Whitepaper
Stable isotope-labeled compounds
Whitepaper
Unlocking the potential of high-throughput screening: Symegold library design and expansion insights
Interviews
Insights into drug discovery and development 2025
Interviews
Interview with the computer-aided drug design (CADD) department
Interviews
Meet the Organix Director, Mario Gonzalez
Interviews
Interview with the new Managing Director of Symeres Groningen
Interviews
An interview with Yadan Chen and Paul O’Shea
Interviews
An interview with Anu Mahadevan and Paul Blundell
Blog
Crystalline and liquid crystalline 25-hydroxy-cholest-5-en-3-sulfate sodium and methods for preparing same
Webinar | On-demand
In vivo pharmacokinetic experiments in preclinical drug development
Webinar | On-demand
Accelerating medicinal chemistry by rapid analoging
Webinar | On-demand
Solid-state chemistry part II: Optimal form selection by controlled crystallization
Webinar | On-demand
Route scouting for kilogram-scale manufacturing of APIs
Webinar | On-demand
Solid-state chemistry part I: Introduction
Speak with our formulation and analytical development experts
See how we can support your integrated, or stand-alone discovery and development program