GMP Manufacturing Services

Reliable drug substance manufacturing services

Our GMP manufacturing services provide reliable, phase-appropriate support from preclinical development through clinical supply.

With over 30 years of pharmaceutical process and CMC development expertise, we design and scale robust chemical processes that deliver high-quality APIs and intermediates.

Our multipurpose GMP facilities combine solid-state chemistry, analytical validation, and crystallization control to ensure consistency, compliance, and dependable timelines.

Whether for GLP toxicology or IND-enabling studies, our integrated approach gives you the flexibility and confidence to move from lab to clinic efficiently

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GMP starting materials

Clinical formulation development and analytical services

Drug product

25+ years’ experience

Proven success delivering GMP manufacturing for complex small molecules, ensuring quality, compliance, and reliable clinical material supply.

10 - 1,000 L flexible scale

Multipurpose GMP facilities tailored to project phase, supporting efficient transitions from lab-scale synthesis to clinical production.

80% repeat partnerships

Relied on by global biotech and pharma for consistent results, transparent collaboration, and on-time, high-quality GMP delivery.

Chemistry, manufacturing and controls

Our GMP manufacturing services are closely connected to broader CMC capabilities – from Drug Substance development and Regulatory Starting Materials (RSM) production to clinical formulation, analytical development, and Drug Product manufacturing.

By integrating chemistry, manufacturing and regulatory insight, we ensure technical consistency, reliable supply and clear documentation that speeds up your path from early development to IND submission.

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What do our partners say?

“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

“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

“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

“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

“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

Your discovery and development partner

We support small-molecule programs from discovery to IND with openness, agility and scientific depth. Our transatlantic teams integrate chemistry, biology, ADME and CMC expertise to deliver seamless progress across development stages.

With transparent data sharing and proactive collaboration, we keep your program connected, compliant, and moving forward – whether as a standalone project or part of a coordinated, multidisciplinary partnership.

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Resources we think you'll love

Blog

CDMO red flags you can’t ignore: Regulatory shortfalls and misalignment

Part 3: Could Regulatory Misalignment Be Delaying Your Submission? A CDMO can have the best scientists, excellent facilities, and strong technical execution, yet still fall short when it comes to regulatory alignment. This disconnect between scientific performance and regulatory readiness is one of the most damaging red flags in drug development as it could delay […]

Reliable drug substance manufacturing services

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