Synovel Laboratory, LLC

About Synovel Laboratory, LLC

Synovel Laboratory LLC is an integrated Contract Research Organization (CRO) of medicinal/process and analytical chemistry support for pharmaceutical R&D. Stemming from our talented synthetic/process chemistry team, we provide variety of products such as API starting material and intermediates, comprehensive collection of clinical reference compounds and synthetically useful, “drug-like” building blocks for small molecule pharmaceuticals research. From our experienced leadership of medicinal chemistry, we will provide “full service” medicinal chemistry support including compound design, candidates synthesis and medicinal chemistry project consultation, for research organization customers. Our experienced process chemistry team provides development chemistry service, such as process chemistry synthesis optimization, primary salt screening, primary crystal form determination, polymorph analysis and large scale (kg quantity) of non-GMP API intermediate preparation. This will serve the chemistry needs of pharmaceutical companies and small-startups to advance their candidates to IND enables stage. Our DMPK and Regulatory Services includes: • Analytical Method Development HPLC/UV and LCMS Metabolite ID and metabolic stability assessments • GLP compliance: Custom software and tools for bioanalysis (database development using file maker pro for tracking functions and sample management) • Consulting in Pharmacokinetics - code development for PK and statistical evaluation using the R program • Document preparation for IND, BLA and NDA Submissions. • Response to queries from regulatory agencies – FDA, EMA, PMDA