Exemplify FAQs

Exemplify is a full-service Contract Research Organization (CRO) located in Cranbury, New Jersey, specializing in end-to-end CMC (Chemistry, Manufacturing, and Controls) development. We support drug substance and drug product development from preclinical through Phase 3 — all under one roof. Exemplify is a part of Symeres,(https://symeres.com/) a leading European-U.S. CRO network with over 700 scientists across Europe and North America. This allows us to offer expanded capabilities in drug discovery, drug development and manufacturing.

Our 18,500 sq ft R&D and cGMP facility is located in Cranbury, New Jersey — located in the tri-state area, just 35 miles from Newark Airport. The facility supports both drug substance (DS) and drug product (DP) development.

Yes — we provide GMP API and clinical formulation manufacturing at kilogram scale, including DS/DP analytical testing, release, and stability under ICH conditions.

We combine consulting, R&D, and GMP manufacturing within one integrated facility, providing a single point of contact for clients. Our model eliminates the need to manage multiple vendors and accelerates IND and NDA readiness.

Our key capabilities include full spectrum IND enabling CMC: • Process Chemistry: route scouting, optimization, scale-up, commercial route development, and clinical trial material manufacturing • Analytical Chemistry: method development, validation, and cGMP release testing • Formulation Development: preclinical toxicology formulation, preformulation and clinical formulation, ICH stability, and GMP manufacturing • CMC Regulatory and Quality Assurance: IND/NDA authorship, audits, and vendor qualification

It means Exemplify handles every stage of CMC — from early process and analytical development to cGMP manufacturing, stability, and regulatory support — within one organization. This reduces handoffs, timelines, and compliance risk.

Absolutely. Our CMC regulatory experts provide IND, NDA, and MAA authorship, control strategy, and PAI readiness consulting, helping clients achieve smooth regulatory submissions.

Our Pharmaceutical Science Department supports solid, liquid, and complex dosage forms, including: • Immediate- and extended-release tablets • Enteric-coated and gastro-retentive formulations • Suspensions, solutions, and sprinkle formulations • Topical and pulsatile drug delivery systems

We offer comprehensive analytical method development and validation using state-of-the-art instrumentation, including LC-MS/MS, HPLC, GC-MS, XRPD, TGA, DSC, dissolution testing, and photostability chambers per ICH guidelines.

We partner with biotech and pharmaceutical companies of all sizes — from early-stage startups to large pharma — seeking a flexible, science-driven CRO partner that can accelerate timelines from lead optimization to Phase 3.

Our team manages SOPs, vendor qualification, audits, document review, and training. We maintain stage-appropriate quality systems to ensure compliance with FDA and EMA expectations.

Our scientists have experience across oncology, CNS, infectious diseases, inflammation, and other therapeutic areas — supporting small-molecule APIs and complex formulations.

Absolutely. Exemplify supports grant applications with program milestones, scope, resource and budget planning, including letters of support.

You can reach our Director of Business Development, sandy.brown@symeres.com (mailto:sandy.brown@symeres.com)to schedule a call and learn more about our CMC development and GMP manufacturing services.