Who we are
ImprovementatWork is a consulting business which supports biotech and pharma businesses in their first NDA/MAA to FDA/EMA or other agencies. Our submission experts work as part of an integrated team with internal regulatory and project management teams, thinking through every detail to ensure organizational readiness for submission.
What we do
Even the best teams need a helping hand.
We combine soft skills with robust processes via our specific approach, Excellenza.
Find out more on how we can help you.
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“We hired ImprovementatWork to design and execute the BLA and MAA submission process for Bapineuzumab, the Alzheimer’s Disease mAB that Janssen developed jointly with Pfizer.”
Frederic Godderis, VP R&D Leadership / R&D Operations / Portfolio & Program Management
“They greatly enhanced our workflow and communications which allowed us to file a high quality, successful BLA and MAA ahead of schedule and much faster than industry norms.”
Mark Goldberg, former Executive Vice President for Medical and Regulatory affairs
“Johan and Anne-Marie provided peace of mind that someone was “minding the store,” so that I could stay focused on the content of the company’s first major marketing applications.”
A senior Regulatory Affairs professional based in Massachusetts
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Contact us to find out how we can be your crew for success.
Senior Director Submission Process
Senior Manager Submission Process
Director Submission Process