Ralph Donnelly has seen 20 years of consulting in the pharmaceutical industry ups and downs. As president and CEO of R. Donnelly & Associates, Inc., he provides consulting to integrate FDA/regulatory compliance with improving productivity for FDA regulated industries. This takes many forms such as project management, facility construction and renovation, process improvement, validation services and quality systems development.
“Our biggest challenge is to keep up with FDA regulations, and provide value added consulting services to our biotech, pharma, medical device and our new dietary supplement clients. While we’ve taken a real hit with the downturn in the economy, we’ve had some positive takeaways from it,” says Donnelly. “Our focus has changed from supporting growth in these industries to maximizing integration of production and plant services to maximize their profits.”
Specifically, Donnelly states that many of our clients expansion programs and some non-regulatory requirements have been cut. Also, some pharmaceutical companies production has moved to other countries. “While this hurt our business, this has also provide the motivation to rethink the business model and services ” Donnelly said. the original plan was to build a consulting firm that has value with it’s employee’s and client base. “At one point I wanted to merge, but quickly found out that the economic downturn has changed the business model. We need to never loose sight of company’s bottom line while growing. Profitability must be maintained by continuously changing to meet the ever changing business climate.
For more inofrmation, please visit: www.rda-group.net
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