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Unger-Bady Consulting & Services

Management Consulting for Regulatory Compliance in the
International Pharmaceutical Industry

Regulatory Compliance cannot be “tested into” a company.
It needs to be generated by the internal process!
I am happy to support you with planning and implementation

Services

I offer management consulting for regulatory compliance to Quality Management, Product Supply and Regulatory Affairs roles within pharmaceutical companies.

Practical Experience

Are you looking for practical experience in regulatory compliance?

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Risk assessment

Are you looking for a way out from too many changes?

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Reliable Data

Are you tired of searching instead of finding?

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Workflows

Do you need better processes and defined interfaces?

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Benefits

Being able to find regulatory data and information instead of searching for it, leads to safety and efficiency and provides the basis for risk-based decision making. Capacity is set free to handle the really important things.

Additionally, streamlined and manageable processes – where the individual and the system work well together – allow faster processing of submissions and thereby quicker finalization of changes. The business may realize savings faster.

Good data and processes enable the qualified person to reliably check compliance with the marketing authorization for each batch release and thereby avoid findings during inspection.

-regulatory compliance is ensured-

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What I do…

I support my clients within the pharmaceutical industry with a focus on regulatory compliance by:

Analysis, individual consultation, implementation

Project management,
interim management

Business analysis

Coaching and Training

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Dr. Mónica Graciela Unger-Bady

Pharmacist-Systemic interactive coach.
Independent consultant since 2007

Before starting my own business, I spent nearly 20 years working in Regulatory Affairs and in a leading position at the interface of the GMP-environment. Since 2007 I have been advising and coaching executives of renowned pharmaceutical companies…

Partners

In order to cover all my clients’ requirements, I work together with selected independent professionals along the entire value chain of the pharmaceutical industry, as well as with IT-specialists for quality management and experts for GxP-regulated disciplines.

Pivotal to the success of

my projects is,…

… the fact that I design and generate unambiguous data and stringent flows of information which can be converted using technology, so in a way I generate…
…the “I” in IT

…the fact that I use my extensive practical experience and my neutral perspective to quickly analyze the situation and the interfaces within and beyond Regulatory Affairs. Together with the position holders I define the roles and responsibilities and develop manageable processes so that…
… role, individual and system fit!

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Seminars and publications

It’s a pleasure for me to share my experience with my clients – whether via publications, interactive seminars or within personalized in-house workshops, which I design specifically for each client.