Exemplar Compliance | Quality FDA Consulting & Remediation

Working With Exemplar

Industry Experience

We have over 60 consultants from across the lifescience industry, including regulatory compliance experts, lead auditors, chemists, former FDA officials, and FDA Quality System (QSR) experts.

Real Results

Get results, not recommendations. We provide real solutions for our clients’ quality & regulatory challenges. Problem identification, analysis, and action are the proven ingredients to our success.

Custom Solutions

Not all quality systems are the same, but they can all be compliant. We work to understand your product and encourage risk-based decision making that meets regulatory expectations.

Experience the Exemplar difference. →

Our former FDA and Industry Experts have an average of 25 years of experience.

25 Years

Product Experience

Exemplar Compliance works with a wide range of pharmaceuticals and medical devices.
Some of our capabilities include:

Drug Product

Drug Products

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 Substance

Drug Substances (API)

We perform on-site audits to qualify API manufacturers world wide. We also conduct API batch record review and remediation activities.

Medical Device

Medical Devices

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.

IVD

IVDs

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.