For more than 20 years, experts at Becker Consulting have helped client companies meet and exceed FDA requirements for developing, testing and marketing innovative healthcare products. We offer Becker™ quality services in the following practice areas:
- REGULATORY | Approval Strategy, FDA Interactions, Advisory Panels, 510(k), PMA, NDA and Other Submissions
- COMPLIANCE | Quality Systems, cGMPs, Audit Preparedness, Form 483s, Warning Letters, Consent Decrees
- TRIALS | Preclinical and Clinical Study Design, Biostatistics, CRO Management
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- ANALYSIS | Expert Opinion, Due Diligence, Litigation Support
NSF Becker & Associates Consulting Inc. Launches New 360 Corporate Compliance Program for the Life Sciences IndustryNSF 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Becker Daily Dose - February 11, 2013Today, FDA announced the availability of a draft guidance document entitled, “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify when a potential change to a device is a recall, distinguish between those changes and product enhancements, and to identify the reporting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.Read More |
Follow NSF InternationalIn 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 AgenciesThe 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 QualityFollowing 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. |
Staff NewsElaine Messa, Executive Vice President, Medical Device Practice, Becker Consulting, will be co-chairing the Ninth Annual Medical Device Quality Congress, May 16-18, 2012. The Congress includes presentations by both current FDA officials as well as industry leaders, and will focus on the five areas where FDA targets its enforcement.Congress Website |
Becker Consulting - FDLI Diamond SponsorBECKER CONSULTING is pleased to be a Diamond Sponsor at The Food and Drug Law Institute (FDLI) Annual Conference, being held April 24-25, 2012 at the Ronald Reagan Building/International Trade Center in Washington, DC. We look forward to seeing all of our Daily Dose readers who will be attending the conference at our booth in the exhibit hall. |
Becker & Associates Consulting, Inc. Welcomes Six Leading ExpertsBecker & Associates Consulting, Inc. is proud to announce the newest members and affiliates of the BECKER CONSULTING team:• Mary Getz, PhD – Director of Quality Systems, Medical Device Practice • Larry Schum – Principal Consultant • Carrie Neuberger – Director of European Strategies • Merry Lee Bain – Regulatory Expert We are also excited to welcome two members of our Expert Advisory Committee as full expert consultants on the Becker team: • Tim Ulatowski – Compliance Expert; Regulatory Expert • Wally Pellerite – Compliance Expert |
Staff NewsAndy Papas, PhD, Director of Regulatory Affairs for the Pharmaceuticals and Biologics Practice at BECKER CONSULTING, and Daniel Kracov, Partner and Head of the FDA and Healthcare Regulatory Practice Group at Arnold & Porter LLP, will be leading a webinar for BioWorld entitled, “Critical Industry Update: Biosimilar Product Development.” Dr. Papas and Mr. Kracov will address key developments in the regulatory landscape for biosimilar products, specifically discussing important topics contained in recently released FDA guidance documents related to biosimilars, as well as considering other important issues for the biotechnology industry. This interactive webinar will be held next Wednesday, April 18, 2012 from 2-3:30 PM ET, and details on how to join the conference can be found here.BioWorld Webinar |
Join Our TeamBecker & 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 youContract-Based Employment at Becker & Associates, Inc. |
Grand Rounds with Tim UlatowskiTim 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 KickoffLooking forward to working together with you to make 2012 a productive and successful year.Full Image |
Staff NewsHarold "Wally" Pellerite, Director of the Medical Device Compliance Committee at Becker Consulting, will speak on a panel during the “Enforcement, Litigation and Compliance Conference” held by the Food and Drug Law Institute (FDLI) on December 6-7, 2011, at the Westin Georgetown in Washington, DC. Mr. Pellerite will be discussing quality and recall issues during the December 6 afternoon panel on “Medical Product Safety.”Conference Information |
Press ReleaseBecker & 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 |
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