From January 1st 2014, Becker & Associates Consulting changes its name to NSF Health Sciences. The team continues to help client companies meet and exceed FDA requirements for developing, testing and marketing innovative healthcare products. We offer NSF Health Sciences quality services in the following practice areas:

Featured Articles


Executive Vice President of NSF Becker and Associates, Maxine Fritz oversees the firm’s pharmaceutical and biologics compliance work, providing both direct support and project management services to clients in the pharmaceutical and biologics industries.

Maxine along with other NSF professionals have written several articles focused on quality in the pharmaceuticals

Don’t Overlook Packaging and Labeling When Developing Your Pharmaceutical Quality System

Materials Management Key to Pharmaceutical Quality

Pharmaceutical Quality – A Closer Look at the Quality Subsystem

The Six Subsystems of a Pharmaceutical Quality System

Are You Ready to Build a Culture of Quality?

Foundations of Pharmaceutical Compliance for Beginners

NSF Becker & Associates Consulting Inc. Launches New 360 Corporate Compliance Program for the Life Sciences Industry

NSF Becker & Associates Consulting, Inc., part of  global independent public health organization NSF International, has launched a new program to assist companies in achieving 360 operational compliance to the commercial practices of the life science industry.  Industry veteran Francisco (Frank) T. Rivas, who has more than 25 years’ experience in all aspects of the pharmaceutical, diagnostics and medical device industry, has been appointed to lead the NSF Becker Corporate Compliance Practice Group.

Press Release

NSF International Announces Acquisition of Becker & Associates Consulting, Inc.

NSF International has announced the acquisition of Becker & Associates Consulting, Inc.

NSF International, founded in 1944, originally as an offshoot of the University of Michigan School of Public Health, is today an independent, global public health and safety organization which develops product standards as well as tests and certifies products for food, water, health, and consumer products.

The integration of Becker & Associates Consulting, Inc. and NSF International offers NSF a broader scope of services and wider experience in the areas of pharmaceutical and medical device regulation, and global quality systems.

Please find a full press release below, as well as the ad which will run in major papers in the coming days.

Press Release

Advertisement

Becker Daily Dose - February 11, 2013

Today, FDA announced the availability of a draft guidance document entitled, “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.”  This draft guidance intends to clarify when a potential change to a device is a recall, distinguish between those changes and product enhancements, and to identify the reporting requirements for both recalls and product enhancements.
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Follow NSF International

In order to learn more about NSF International, and follow recent updates about the company's services to protect human health and the environment, use the links below to connect to NSF International on Facebook and Twitter.

NSF International on Facebook

NSF International on Twitter

NSF Health Sciences on Twitter

Food and Drug Law Journal - Your Business in Court and at Federal Agencies

The Food and Drug Law Journal (June 2012) published its annual article, “Your Business in Court and at Federal Agencies: 2010-2011,” that examines agency behavior, court decisions and legislative developments that affect FDA-regulated businesses.  The authors found that enforcement data demonstrates that the “government continues to aggressively pursue Manufactures…”  and noted that FDA is “undertaking initiatives with foreign agencies and stationing larger number of FDA employees in foreign countries.”  The article concludes with the recommendation that “Companies must evaluate their internal compliance mechanisms and make sure they are positioning themselves to handle the new enforcement environment.”

For more information:
Preview of Article
FDLI

FDA Pathway to Global Product Safety and Quality

Following recent enforcement actions taken by FDA against global pharmaceutical and medical device companies, renewed interest has been generated towards a report published by FDA entitled “Pathway to Global Product Safety and Quality.”  In the report, FDA states that the rise in number of imported drugs and devices has led the Agency to expand “its capabilities and regulatory authority.”  Additionally, FDA has opened additional offices in key international locations and materially increased the number of certain types of foreign inspections.

As a service to our colleagues, please find the Special Report linked here.

Becker & Associates at FDLI's "The Intersection Worlds of Drug, Device, Biologics, and Health Law"

Please join BECKER CONSULTING at the Food and Drug Law Institute’s conference on “The Intersecting Worlds of Drug, Device, Biologics, and Health Law” next week at the St. Regis hotel in Washington, DC.  The conference, co-sponsored by the American Health Lawyers Association, will take place on Monday and Tuesday, May 21-22, and will address three significant areas of intersection in FDA and Health Law:  reimbursement, fraud and abuse, and research/clinical trial issues.  More information and registration are available here:  
http://www.fdli.org/conferences/conference-pages/the-intersecting-worlds-of-drug-device-biologics-and-health-law.

Upcoming Events

RAPS -- Boston, MA, September 28-October 2

AAPS -- San Antonio, TX, November 11-14

4th Annual West Coast Compliance Congress -- San Francisco, CA, November 12-20

FDLI Enforcement Conference -- Washington DC, December 10-11

11th Annual Pharma Compliance Congress -- Washington DC, January 28-29, 2014

Grand Rounds with Tim Ulatowski

Tim Ulatowski, former Director of the Office of Compliance at FDA's Center for Devices and Radiological Health, spoke at Becker Consulting this afternoon regarding his background and experiences at FDA over his 36 year career with the agency.   Included was a discussion of the interactions between the Offices of Device Evaluation and Compliance, current FDA trends, initiatives, and enforcement actions.  Mr. Ulatowski now serves as a Director on the Becker Consulting Expert Advisory Committee.

Becker 2012 Team Kickoff

Looking forward to working together with you to make 2012 a productive and successful year.

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Press Release

Becker & Associates Consulting, Inc. (Becker Consulting) is proud to announce the addition of Tim Ulatowski, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), as Director, Medical Devices on the Becker Consulting Expert Advisory Committee.  Mr. Ulatowski has over 36 years of public health experience, including more than 25 years in multiple leadership positions at FDA’s CDRH.  

Press Release

Did you know?

Of the Fortune 500, Becker Consulting serves:  
  • 5 of 6 in Medical Products & Equipment;
  • 8 of 12 in Pharmaceuticals;  
  • 3 of 4 in Scientific Equipment; and
  • 4 of 6 in Household and Personal Products   
We also serve the #1 in each sector.




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BeckerTM Daily Dose

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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