Becker Compliance offers Quality Systems and Compliance consulting services to FDA-regulated industries worldwide. We specialize in the timely and efficient resolution of compliance issues and in the development of robust quality systems. Our experts are distinguished by long FDA careers, industry experience, and a reputation of reliability and success.

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Becker Compliance Asia

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Join Our Team

Becker & Associates, Inc. is looking for skilled compliance and regulatory experts to join our team on a contract basis.  Do  you have FDA and/or industry experience with medical device, pharmaceutical, or biologics regulation and compliance?  Please use the link below to learn more and to contact us regarding the positions available.  We look forward to hearing from you

Contract-Based Employment at Becker & Associates, Inc.

Staff News

Ron Ginor, MD, Chief Executive Officer of Becker Consulting, spoke on a panel during the “Issues in Global Health: Advancing Efficiency and Quality through Regulatory Science” symposium sponsored by the Johns Hopkins Carey Business School and the Food and Drug Law Institute (FDLI) on December 2, 2011, at the National Press Club in Washington, DC.   Dr. Ginor used case studies and recent examples to speak to the regulatory realities facing manufacturers and affecting public health officials during the second morning panel on “Realities of Global Compliance.”  

JHU News Release
Symposium Information

Staff News: Becker at MichBio 2011

Ron Johnson, President, and Elaine Messa, Executive Vice President of the Medical Device Practice, at Becker Consulting presented on quality and compliance issues yesterday at the MichBio Expo & Conference in Grand Rapids, MI.

Mr. Johnson:  Evaluation, Internal Audits and Compliance for Contract Suppliers

Ms. Messa:  CAPA – Creating a Culture of Quality

MichBio 2011

Staff News

Becker Facilitates USC Group Visit to CPIER, Beijing

Becker & Associates Consulting, Inc. (Becker Consulting) facilitated and participated in a September 23rd meeting in Beijing, China between two leading academic organizations in the area of regulatory science:  the University of Southern California (USC) and Peking University.  

Dr. Frances Richmond, Professor of Clinical Pharmacy and Director of Regulatory Science Program, led the group of USC graduate students from this pioneering professional doctorate program in regulatory science.  

Dr. Qiang Zheng, Director of the Center for Pharmaceutical Information and Engineering Research (CPIER), along with representatives from the Peking University Office of International Relations, hosted a discussion on recent developments in the regulation of pharmaceuticals, medical devices and food in the US and China.

Group Photo

Staff News

San Diego Regulatory Affairs (SDRAN) and Orange County Regulatory Affairs (OCRA) are sponsoring an educational program on corporate compliance. We have assembled speakers on many of these topics including attorneys, corporate compliance officers, and government officials to inform us.

BECKER CONSULTING’s Elaine Messa, Executive Vice President of the Medical Device Practice, is managing this year’s program, which addresses corporate compliance challenges in the midst of FDA’s current enforcement climate.

Join us on Oct. 19 for a one day conference to learn about these pressing topics and how you can help your company meet and maintain compliance in a challenging and changing regulated world of medical products.  Register here: http://ocra-dg.org/.

Staff News

Becker & Associates Consulting, Inc. (Becker Consulting) is proud to announce the addition of Ron Johnson, former Director of the Office of Compliance within FDA’s Center for Devices and Radiological Health (CDRH) and Director of FDA’s Pacific Region, as President of Becker Consulting.  

Mr. Johnson joined Becker Consulting as of September 1, 2011, and is available immediately to provide compliance and enforcement guidance to FDA-regulated companies and their counsel.

Press Release

Staff News

BECKER COMPLIANCE announces Donna Simmons and Tony Luttrell as the first recipients of the “Most Valuable Professionals” award for excellence in compliance consulting. Ms. Simmons and Mr. Luttrell were also awarded Apple iPads in recognition of their exceptional service, professionalism, and commitment to providing clients with robust compliance solutions.

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Becker Compliance Asia in Beijing

Becker Compliance Asia, a Diamond Sponsor of the US Food and Drug Law Institute first seminar in Beijing, has sent a delegation to Beijing to help present and clarify issues related to the manufacturing and importation of regulated products into the US market.  Becker Compliance Asia is the leading US Compliance practice to develop a full set of compliance materials in Mandarin and has taken an active role in developing and distributing the first English translation of SFDA regulations in history.  

Additional Information
Brochure

Staff News

Becker Compliance's Elaine Messa, Executive Vice President, Medical Device Practice, will co-chair the 8th Annual Medical Device Quality Congress, hosted by FDAnews.  


The Congress, held June 9-11 at the Marriott Bethesda North Hotel & Conference Center in Bethesda, MD, features 10 CDRH Officials and 5 former FDAers.


Brochure

Translation

Becker Compliance Asia made available the first comprehensive English translation of the China State Food and Drug Administration (SFDA) Good Manufacturing Practices (GMP) for Pharmaceuticals (2010 revision) at the FDLI China conference, which was held in Beijing on June 13- 14.  This authoritative translation was produced by the Peiking University Center for Pharmaceutical Information and Engineering Research (CPIER), and includes Annex 1 for sterile pharmaceutical products.

Download SFDA GMP Booklet

BeckerTM Daily DoseTM

The Becker™ Daily Dose™ keeps readers informed with the latest FDA regulatory and compliance news, important policy and legislation updates, and coverage of upcoming panels and meetings.




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BioWorld Insight Interview

Maxine Fritz, Director of the Pharmaceutical and Biologics Quality Systems and Compliance Practice at Becker Consulting, was recently interviewed by BioWorld Insight regarding the compliance challenges inherent in scaling up the production of biologics.




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