Exemplify Biopharma is a Symeres company delivering advanced chemistry and development services to support small molecule programs from lead optimization through early clinical stages.
Our integrated offering spans synthetic chemistry, custom synthesis, formulation, and GMP manufacturing, delivered with the flexibility, expertise, and responsiveness today’s development timelines demand.
Whether you’re refining a lead series, building an IND-enabling package, or scaling for first-in-human trials, Exemplify combines scientific depth, real-world experience, and operational foresight to keep your program moving, with fewer handoffs, the flexibility to adapt as plans evolve, and full transparency at every step.
Exemplify Biopharma Services
Preclinical
Our capabilities include SAR synthetic strategy and intermediate synthesis, salt and polymorph screening, physicochemical characterization, API synthetic route evaluation and scale-up development (kg scale). We also provide comprehensive analytical chemistry, formulation development, and coordinated toxicology and pharmacology studies to support a fully integrated preclinical package.
Phase I
Our Phase I services advance programs seamlessly into early clinical development under full cGMP compliance. We offer GMP API synthesis (kg scale), analytical method development and validation, release and stability testing, and formulation development supported by pre-formulation and solid-state characterization. These services are complemented by cGMP CTM manufacture and IND/eIND and IMPD documentation support to enable a confident transition into first-in-human studies.
Phase II
Our Phase II services focus on optimizing processes and scaling for late-stage development. We offer API route scouting and pilot-scale development, polymorph and crystallization screening, and PMF and specifications development to ensure robust, cost-effective manufacturing. Comprehensive analytical method development and validation, along with cGMP release and stability testing, support smooth progression toward commercial readiness.
Phase III
Our Phase III services support late-stage development and commercial readiness with full cGMP compliance. Capabilities include analytical method development and validation, release and stability testing, and specialized expertise in PGI methods, impurity and degradant identification, and reference standard synthesis. We also provide commercial formulation support and comprehensive regulatory documentation for ANDA, NDA, MAA, and DMF submissions, ensuring a seamless path to market approval.
Part of Symeres
As part of Symeres, Exemplify BioPharma operates within an integrated drug discovery and development network that spans the entire journey from hit finding to clinical manufacture. Exemplify’s expertise sits within the Preclinical and early Clinical Development stages supporting API route development, analytical and formulation work, and GMP manufacture for Phase I–III studies, while drawing on Symeres’ broader discovery chemistry and ADME-Tox capabilities to deliver truly end-to-end support.
Our Laboratory
Located in Cranbury, New Jersey, Exemplify BioPharma’s 18,500 sq. ft. R&D laboratory is purpose-built to support every stage of preclinical and early clinical development. Our facility houses state-of-the-art suites for process, analytical, and formulation development, along with cGMP release testing for both drug substance and drug product. From concept to clinical readiness, our teams work collaboratively under one roof to deliver quality, efficiency, and scientific excellence.
Get in Touch
Let us know a little bit about your project or interest in Exemplify. Our team will follow up promptly to discuss how we can support you.
