The problem
In every sector we're aware of, FDA regulated organizations get the same thing wrong year after year after year. We take that to mean or more of the following:
- regulations are complex and people who have to make sure their prodcuts adhere to the reguations need some help
- senior management/executives overestimate how their organization performs compared to the sector
- When managers are allocating resources to maintain compliance, they don't know where they get the most bang for their buck
What this is, and is not
First off - This is not a band aid. As far as we're aware, there are any ways to paper over a deficient quality deficiencies. That's not to say we don't believe there is no low hanging fruit to be found, that's something we've seen firsthand is the case. Having said that, what this will do is help focus efforts. Whether or not the FDA announces it publicly, in every sector - Drugs, Medical Devices, Foods, Veterinary and Biologics - there are regulations with higher enforcement priorities than others. It is a fact that there are some regulations that are hardly ever enforced.
Who is this for?
- Any FDA regulated company that wants to get a better handle on their regulatory and quality risk. Specifically these sectors
- Biologic
- Food / cosmetic
- Medical device
- Pharmaceutical
- Veterinary
Our approach
- Give executives and senior management a tool to better understand how their organizations compare to the industry as a whole and better assess risks.
- Give middle and line managers implementing quality policy a tool to understand where to where they get the most benefit
- Give engineers and scientists a tool to better undertand what the regulations mean and how they apply
Like how any of that sounds?
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