About

EXPERIENCE | EXCELLENCE | LEADERSHIP

With over thirty years of industry experience, we have served all areas of FDA-related activities for the Pharmaceutical, Biotechnology, Biologics, Medical device and Consumer healthcare Industries.

We serve a diverse base of loyal clients around the globe in implementing robust processes that identify compliance gaps and developing strategies for sustainable compliance to corporate policies and governmental regulations, including: FDA/Quality System Requirements and ISO standards for Medical devices.

The associates of GMP Consulting LLC are experienced in managing and restructuring departments under consent decree injunctions, FDA-483s and Warning Letter observations, into GMP-compliant units that met (and exceed) verification activities.

GMP Consulting Core Principles

Competence

Our expert consultants have proven expertise in the areas of quality systems and GMP compliance. With a minimum of two decades of industry experience, we bring sound judgment in working with companies.

Objectivity

In our daily operations, we work with your company to provide accurate, unbiased, and sound regulatory advice which takes into account all opportunities and risks.

Independence

As consultants, we maintain independence from third parties, especially when decisions about suppliers or other vendors need to be made.

Confidentiality

Our consultants treat all of the knowledge and information gained during the consulting process with the utmost confidentiality.

Marie J. Florestal

I am a seasoned Quality and Compliance Professional with thirty-years of extensive experience in the pharmaceutical, biotechnology, consumer health and medical device industries.

During my tenure in the industry, I have been privileged to have worked for and consulted with various major pharma and medical device companies; including Novartis, Celgene, McNeil Consumer Healthcare and Stryker, to name a few. In my professional career, I have accomplished various milestones and accolades, including, but not limited to:

Managing Quality and Compliance teams to ensure integrity of data for the product release and supplier management activities, including approval of quality agreements, audits and supplier corrective actions.

Implemented a training program for conducting effective quality systems investigations that incorporates identifying the nonconformance, implementing appropriate containment, determining the root cause, implementing actions to correct the nonconformance, and validating or verifying that those actions will work and will not adversely affect the product.

Successfully leading regulatory inspections, submitting satisfactory observation responses and coordinating FAR activities.

Managing teams and personnel to eliminate noncompliance and ensure a robust and sustainable organization.

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