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Regulatory Compliance for

Life Sciences Companies

Speak to the experts in regulatory compliance and quality systems consulting.

We bring decades of compliance experience across 500+ companies in the life sciences space.

Upgrade your processes to improve your business systems and remain in compliance.

We save you time and money by integrating with your team, and by not charging an arm and a leg to do it.

Meet Our Team

Melita Ball, CEO & Principal Consultant

Melita is the founder and CEO of MBCA. She graduated cum laude from George Washington University. She then spent 20 years working in life sciences, working for Siemens, Hollister, etc. Melita has hired and trained twelve other extremely talented consultants that work at MBCA.

Frank Fokta, PhD,

Senior Consultant

Dr. Fokta has over 20 years of experience in quality control, quality assurance, manufacturing, hardware qualification, and software validation in the medical device, diagnostics and pharmaceutical industries. He also holds a doctorate in Molecular Biology.

Julie Chaffee,

Senior Consultant

Ms. Chaffee is a quality assurance and regulatory affairs professional with over 30 years' experience in manufacturing and service within the medical device, in vitro diagnostic, biologic, biotechnology, pharmaceutical and laboratory service industries.

LaDahvia Flournoy Fowler, Associate Consultant

Ms. Fowler has over 12 years' experience implementing and maintaining quality management systems, streamlining processes and executing audits in FDA-regulated industries. She has an in-depth knowledge of regulatory requirements and standards and holds an MS in Biotechnology.

"MBCA has been our go-to resource and partner for our Quality System and Compliance Needs. [Melita's] ability to "translate" the regulations across functional teams and at varying levels of maturity and understanding has made her services invaluable."

Jade Kondo, VP of Quality

System and Compliance

Eric Henry, Senior Quality & Regulatory Compliance Advisor

"I had the pleasure of working with Melita Ball  to prepare staff for an imminent FDA inspection. Melita was extremely knowledgeable and a superb coach. I continue to recommend Melita and her firm to both life sciences companies and to colleagues with world class regulatory and compliance skill sets. 

MBC & Affiliates, Inc

Work With Us

Fill out the form below to speak with someone from our team.

 

Phone:

520.665.9081

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©2020 by MBC & Affiliates, Inc.