Question 1

What does Exemplify do?

Accepted Answer

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, 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.

Question 2

Where is Exemplify located?

Accepted Answer

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.

Question 3

Does Exemplify support GMP manufacturing?

Accepted Answer

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

Question 4

How is Exemplify different from other CROs?

Accepted Answer

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.

Question 5

Does Exemplify offer integrated CMC services?

Accepted Answer

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

Question 6

What does “end-to-end CMC under one roof” mean?

Accepted Answer

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.

Question 7

Can Exemplify support IND and NDA filings?

Accepted Answer

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

Question 8

What kinds of formulations can Exemplify develop?

Accepted Answer

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

Question 9

What analytical capabilities does Exemplify have?

Accepted Answer

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.

Question 10

What types of clients work with Exemplify?

Accepted Answer

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.

Question 11

How does Exemplify ensure project quality?

Accepted Answer

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.

Question 12

What industries or therapeutic areas does Exemplify serve?

Accepted Answer

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

Question 13

Does Exemplify support grant applications?

Accepted Answer

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

Question 14

How can I contact Exemplify?

Accepted Answer

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

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