Our Story
Be the change you want to see in the industry…
Breaking the Mold – We are a group of industry experts who wanted to change the traditional consulting support that we saw year after year. Many of us came from large companies like Abbott Laboratories, Pfizer, Genentech, Boston Scientific, and Johnson & Johnson; we had hired (and fired) many consultants over the years. Some were better than others, and we generally struggled to find resources that provided value to the organization and true insight. We were looking for consultants that applied regulations, standards, and guidance in a practical manner, keeping in mind business objectives and profitability. We found most consulting services were either too high level or not responsive enough to our needs. We needed clinical and commercial strategies based on our products’ risk profile, not templates. We needed people to get the work done, not “theorize” on a solution or pontificate on regulations for days on end. We didn’t need more meetings – we needed solutions.
In 2011 we left the industry and started Exemplar Compliance, LLC., a small consulting firm specializing in Validation, Quality, and Regulatory Compliance. Within a short period of time we were contacted by former colleagues and adversaries alike who wanted to join our group. People knew we had established something great and they wanted to be a part of it! Our team is comprised mostly of Industry Experts and Former FDA Inspectors/Officials. As simple as it sounds, good people like to work together. This group has grown into the cohesive team that we have today, with services branching across the globe. We love to take on challenging assignments and we only accept projects where we can add value to the organization. That’s the Exemplar difference.
We didn’t need more meetings – we needed solutions.
So we created them.
Experience the Exemplar difference. →
Our Company Motto
“Take interesting projects and work with fun people.”
We believe in the advancement of science and technology.
We believe in an exchange of service for value to the client.
We believe in family, friends, and the enrichment of life.
We believe in teaching our clients as we work.
We believe in you.
Our Mission
Your customers and patients are our mothers, fathers, children, aunts, uncles and friends; so we put the patient health and safety first.
Our Passion
We are passionate about delivering practical quality and compliance solutions. This means that not every company needs to have the same quality system. The Quality system should be appropriate for your intended product and the markets that you are serving.
We are passionate about our people. Our consultants are composed of friends and colleagues that we have worked with through the years. Our people make the difference.
Our clients receive product approvals for biologics, drugs, medical devices, and combination products.
Project Experience
Drugs
| Sterile Injectables | Central Cell Banks |
| Oral Solutions & Liquids | Mental Illness & Depression |
| Oral Solid Dose (OSD) | Breathing/Respiratory |
| Tablets & Capsules | Pain Relievers |
| Transdermals | Diabetes |
| Opthalmics | Oncology |
| APIs & Excipients | Others … |
Devices
| Class I, II, & III Devices | Radiology/ CTs / Imaging |
| Stents | Patient Monitoring (vitals, PB, etc) |
| Catheters & Guidewires | Auto-injectors |
| Othalmics | Inhalers |
| Surgical Closures | Heart Valves |
| Capnography | IVD Test Kits (Diabetes, Allergy, Oncology) |
| Implants | And more |
Exemplar Compliance consultants have over 15 sub-specialities.
What We Do
Is it broken? We can fix it. Do you need it approved? We can help you get it there. Is there are problem? We can investigate and offer scientifically-based solutions. Just need a little extra help? We can provide quality oversight and additional QA/QC staff. Is the FDA at your front door? Call us now and we’ll be there.
Quality consulting done differently.