Our former FDA and Industry Experts have an average of 25 years of experience.
Exemplar Compliance works with a wide range of pharmaceuticals and medical devices.
Some of our capabilities include:
We work with traditional pharmaceuticals as well as cutting edge biological products. From early-phase clinical trials to full scale multinational commercial production – we do it all!
Drug Substances (API)
We perform on-site audits to qualify API manufacturers world wide. We also conduct API batch record review and remediation activities.
We work with a broad array of class I, II, and III medical devices as well as combination products. We provide services to both component and finished device manufactures in numerous treatment areas.
We assist with quality system development and product approval for In Vitro Diagnostic (IVD) devices and RUO products. We also perform CAPA and complaint investigations for US and international products.