Dr. Paul O’Shea, Co-Founder and Chief Scientific Officer of Exemplify BioPharma and Yadan Chen, Co-Founder and Chief Executive Officer
Exemplify BioPharma is a rapidly growing New Jersey-based organization established in 2015 that offers a comprehensive range of Chemistry, Manufacturing and Controls (CMC) consulting and laboratory services for small molecule programs. Exemplify BioPharma provides know-how in Process Chemistry, Analytical Chemistry, Formulation Development, Quality Assurance and Regulatory Affairs through fullservice CMC Consulting and R&D Laboratories. Their expertise lies in providing Investigational New Drug (IND) and New Drug Application (NDA) Enabling CMC support for small molecule programs leading to successful transition from late-stage lead optimization to first in human (FIH) and from Phase III to commercialization.
We serve as a single point of contact for clients from early-stage discovery to the next milestones of their drug development process
Serving as a partner to their clients, Exemplify BioPharma acts as a global Partnership Research Organization (PRO). Through their unique “under one roof” business model, Exemplify BioPharma offers end-to-end CMC program management, functional area coordination, and technical guidance to accomplish strategic, tactical, and regulatory milestones.
Exemplify BioPharma’s prominent position in the industry is the result of over a century of expertise from their sought after scientific advisors.
This consulting team is fluent in the various aspects of drug development, be it CMC- technical oversight, vendor selection and qualification, due diligence, gap analysis, quality assurance, and regulatory Investigational New Drug and New Drug Application (IND and NDA) authorizations. These capabilities illustrate its ability to seamlessly assist clients at any stage of their drug development pipeline.
With their deep knowledge of global regulatory filing guidelines, clients can utilize Exemplify BioPharma’s services for the Food and Drug Administration (FDA), European Medicines Agency (EMA), Japan Pharmaceutical and Medical Devices Agency (JPMDA), and Australian Therapeutic Goods Administration (TGA).
For quality assurance consulting, the firm offers a comprehensive quality management system (QMS) and standard operating procedure (SOP) packages, as well as internal and external auditing services.
“We serve as a single point of contact for clients from early-stage discovery to the next milestones of their drug development process,” states Yadan Chen, Co-Founder and Chief Executive Officer of Exemplify BioPharma.
In response to the demand from their consulting client’s desire for full CMC management services under one roof, Exemplify BioPharma established R&D laboratory capabilities in Cranbury, New Jersey. To compliment the consulting services, Exemplify BioPharma offers contract research services in process chemistry, analytical chemistry, and formulation development. In May of 2022, Exemplify BioPharma expanded into their newly renovated 18,500 sq. ft. laboratory equipped with R&D laboratories and GMP active pharmaceutical ingredient (API) and formulation manufacturing suites.
“Exemplify is committed to delivering the best value to our clients. Our team begins each project by gaining a 360-degree view of the clients objectives and expected timelines. We are prompt to answer our client’s CMC-related queries allowing us to minimize potential bottlenecks during development. In essence, the holistic and innovative portfolio of services aimed at responding to client’s most pressing needs keeps Exemplify BioPharma uniquely positioned to offer full CMC success to every customer.” says Paul O’Shea, Co-Founder and Chief Scientific Officer of Exemplify BioPharma.