Your Fast Track to Submission
Improvement at Work applies a proprietary methodology, Excellenza, which is tailored around the specific needs of your company
Who we are
Improvement at Work is a consulting firm which supports biotech and pharmaceutical companies 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.
Knowledge amplification
Accelerate the learning process in the organization.
Efficiency engineering
In-depth experience with project management and submission planning.
Resource optimization
Gear up for submission by identifying clear roles and responsibilities and the need for additional expertise.
Embedded coaching
Cultural adaptation and team alignment from within.
Find out more on how we can help you.
Extra Service
Improvement at Work can provide dynamic and adaptable regulatory strategy support for early-stage biotech and pharmaceutical companies, including:
- Provide regulatory strategy and experienced perspective to support the overall development of small molecule products.
- Coordinate and deliver high quality, regulatory submissions to support early development and life cycle management (e.g., INDs, CTAs, application amendments, formal meeting packages, orphan drug applications, DSURs).
- Effectively engage FDA to obtain guidance on development strategy and discern Agency expectations.
- Advise on fit-for-purpose best practices and infrastructure build to support compliant development.
- Actively collaborate and work as your integrated team member and regulatory lead.
Corporate values
In our daily interactions with clients and colleagues, these values are at the core of who we are. They define how we work, collaborate and contribute to your success.
INTEGRITY
We operate ethically and with a strong sense of responsibility.
COMMITMENT
We critically consider risks, opportunities and alternative scenarios to identify the best way to accomplish goals.
IMPROVEMENT
We embrace change as part of our desire to learn, innovate and adapt.
EFFICIENCY
We diligently focus on refining processes and aligning efforts to provide clarity and emphasis on the task at hand.
Ready to Gear Up for Your Race?
Like a Formula One pit crew, Improvement at Work will accelerate your submission process with meticulous planning and precise execution.
Anne-Marie GEERTS
co-founder, Principal
Jackie Cinicola
Executive Consultant
Johan TELEN
co-founder, Principal
Stephanie Santiago
Consultant
Jamie Yedlin
Senior Consultant