What is the Fontarôme Advantage?

It is the combination of capabilities, equipment, processes and people that distinguishes us and benefits you. It’s what makes doing business with us smarter and easier than working with our competitors.
 
Quality Assurance Above and Beyond S.O.P
The influence of our QA team permeates our entire organization. Led by our QA Regulatory Affairs Manager who came from Abbott, our procedures are modeled after Big Pharma. To ensure consistency and encourage continuous improvement, we have our own practices in place that are exclusive to Fontarôme in addition to annual internal audits and a modular-based training program and associated competency exams.
Excellent Inspection History
Our FDA relationship and record is outstanding – over 25 years of bi-annual FDA inspections with no 483 responses and only minor observations noted in pre-approval inspecations. We have been registered with DEA since 1994 and, after five inspections, have received no warning letters.
Sleek Process Design
Our SPD not only translates to improved FDA compliance because it lowers the risk of contaminations, results in less wetted surface area and facilitates cleaning, but also helps us keep costs down by increasing productivity and requiring less maintenance and labor.

Drug Development Process
We can be your one-stop shop, working as your API or intermediate resource through all stages of drug development – pre-clinical to commercialization.

Learn more about Our Process >
Prevalence of Glassware
Our use of customized, commercial-scale glassware is beneficial from a FDA compliance and cost standpoint, in addition to easing process scale-up. Cleanliness is easily maintained due to lower porosity and ability to visually monitor the state of the glassware.
Location
In addition to being an intellectual capital of the Midwest, our Milwaukee, WI headquarters provides us direct access to a talent pool that is the ideal skill level for what we do. Here we can maintain our position as a domestic supplier and pass the benefit of lower manufacturing costs onto our customers.