CMC Drug Product Development

Our CMC drug product development services provide integrated support from preclinical formulation through first-in-human studies, and clinical development through Phase III.

This includes drug product formulation and analytical development, and GMP manufacturing services ensuring clinical trial material is delivered to regulatory standards.

Related services

GMP starting materials

GMP manufacturing

Clinical formulation development and analytical services

Drug product development with regulatory confidence

30+ years

Of formulation and analytical expertise supporting clinical development.

Formulation, analytical, and GMP drug product manufacturing

co-located to reduce transfer risks and timelines.

Global regulatory track record

supporting IND and IMPD filings with FDA, EMA and other regulatory authorities.

Integrated formulation and manufacturing

Our CMC drug product services include formulation development for solubility, stability, and bioavailability; analytical validation and stability testing; and GMP manufacturing across solid, liquid, and topical forms.

While integrated partnerships offer clear continuity, we know plans can change – that’s why we also provide stand-alone CMC support to keep your clinical progress on track, without added hassle.

Learn about our quality

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 progression was really phenomenal. I am truly impressed. There is a world of difference between you and other CROs.”

Start-up Founder

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 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

“The team is making short work of these targets, so we will have to start thinking of some additional targets!”

Director

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

“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

“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

Your discovery and development partner

We support programs from target exploration through IND and beyond, combining assay biology, ADME-tox, medicinal chemistry, and CMC development.

With a transatlantic team in Europe and North America, 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 wherever you are in development.

Learn more about us

Resources we think you'll love

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