Your Fast Track to Submission

Improvement at Work applies a proprietary methodology, Excellenza, which is tailored around the specific needs of your company

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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.

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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.

Knowledge amplification

In-depth experience with project management and submission planning.

Knowledge amplification

Gear up for submission by identifying clear roles and responsibilities and the need for additional expertise.

Knowledge amplification

Cultural adaptation and team alignment from within.

Find out more on how we can help you.

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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

Trust, honesty and authenticity are essential to us. We foster a transparent relationship and mutual trust with our clients.

We operate ethically and with a strong sense of responsibility.

COMMITMENT

With a strong sense of determination, perseverance, and reliability in fulfilling obligations, we drive to achieve desired outcomes.

We critically consider risks, opportunities and alternative scenarios to identify the best way to accomplish goals.

IMPROVEMENT

This value, as part of our company name, represents our continuous pursuit to enhance processes, skills, services and ourselves.

We embrace change as part of our desire to learn, innovate and adapt.

EFFICIENCY

We are passionate about optimizing timelines and efficient use of resources during critical periods.

We diligently focus on refining processes and aligning efforts to provide clarity and emphasis on the task at hand.

“ImprovementatWork provided the jumpstart for sNDA planning that the team needed!”

A senior Regulatory Affairs professional based in Massachusetts

“IAW’s level of planning and the granularity with which they programmed our activities was essential to our success. IAW was a pleasure to work with, and I would use them again in a heartbeat. ”

Martha Carter, Chief Regulatory Officer, Albireo Pharmaceuticals

“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

“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

“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

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, Vice-President

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Jackie Cinicola

Vice-President

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Johan TELEN

co-founder, President

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Elle NUGENT

Senior Director Submission Process

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Stephanie Santiago

Director Submission Process

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Jamie Yedlin

Director Submission Process

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