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.
Even the best teams need a helping hand when time is of the essence. Taking the fast track to your first submission involves advance planning and cross-functional coordination to ensure all the components are put in place without wasting any time. ImprovementatWork has the necessary expertise and experience to help ensure that individual plans are synchronized and optimized cross-functionally, in accordance with best practice. We add value by bringing focus to your submission process, highlighting the exact steps that need taking to guarantee success.
Embedded in your team, we will work together to think through how things will be done at a micro level, and to develop an integrated approach for how to translate best practice (generic) processes into company specific, tailor-made process descriptions and overviews that identify and mitigate risks.
ImprovementatWork will ensure your submission is perfectly tuned, turning your race strategy into success.