NSF International Buys Avarent LLC

Ann Arbor, Mich.-based NSF International, a provider of regulatory compliance, quality systems, analytical testing, education and consulting services for the medical device sector, has acquired Libertyville, Ill.-based Avarent LLC, a consulting firm with expertise in medical device products/processes development, design control, validation, quality assurance and regulatory compliance. Avarent will be renamed NSF Avarent.

Terms of the deal were not disclosed.

The addition of Avarent expands NSF International’s portfolio of medical device services to both NSF International and Avarent clients, combining Avarent’s expertise with NSF International’s experience in regulatory compliance and quality management systems throughout the medical device product life cycle.

The acquisition was made through NSF International’s Global Health Sciences Division, and builds on NSF’s 2012 acquisition of Washington D.C.-based regulatory compliance consulting firm Becker & Associates and United Kingdom-based medical device training and consulting firm Pink Associates, as well as the 2011 acquisition of contract laboratory Pharmalytica.

Avarent was founded in 2003 by Ian Fleming, with Thomas Dzierozynski joining in 2006. Fleming and Dzierozynski will join NSF International as executive vice presidents, reporting to Elaine Messa, president of NSF Health Sciences Medical Device Consulting, and will lead the integration of Avarent services into NSF Medical Device Consulting.

“The addition of Avarent’s technical production process and validation services and technical compliance consulting allows us to go beyond traditional consulting services to reduce costs for our medical device customers through improved operational efficiency,” said Messa. “Together, we will provide our clients with more comprehensive solutions that ensure the design and manufacture of safer, higher quality medical devices.”

“NSF International and Avarent share the same commitment to delivering smart solutions focused first on patient safety and regulatory compliance. By combining our expertise, Avarent and NSF clients will have access to leading edge consultants dedicated to optimizing medical device design and manufacturing while mitigating risk and ensuring quality and regulatory compliance throughout the product lifecycle,” said Fleming.

“The client value of our combined organizations extends beyond strategic consultation to offer delivery of optimized solutions that synchronize business goals with compliance needs.  We will work together to increase awareness at all levels of an organization to drive client buy-in and ownership of the enacted solutions,” said Dzierozynski.

Fleming has more than 18 years of experience working in U.S. Food and Drug Administration-regulated industries to deliver system and process improvements for medical device and pharmaceutical companies challenged in balancing business and compliance needs. His experience includes auditing and risk analysis from a compliance and operational perspective as well as assessment, remediation and implementation of quality systems. He has led software/computer system development, remediation and validation efforts as well as 21 CFR Part 11 compliance efforts for enterprise resource planning/manufacturing execution systems, relational and object oriented databases, supervisory control and data acquisitionand process control systems, medical device software, clinical data systems, sample accountability systems, in-vitro diagnostics and laboratory data management. Earlier in his career, Fleming held various roles at Packard BioScience, most recently as senior product specialist, and was a microbiology technologist at North American Science Associates.

Tom Dzierozynski has more than 20 years’ experience in the pharmaceutical, medical device and biologics industries. Through comprehensive and practical knowledge of operations, regulatory affairs and quality systems, he has developed and implemented risk-based strategies that integrate varying business functions to drive ownership and improve operational and quality performance.  He’s led numerous, technically oriented projects focusing on design controls, verification and validation, process improvement, regulatory market clearance, risk management and implementation of corrective actions to address/avert enforcement actions. Earlier in his career, Dzierozynski was vice president of validation services for Quintiles Consulting, and worked at Baxter Healthcare Corporation in diverse quality, engineering and management positions.  
 
As a result of the acquisition, current clients of NSF Medical Device Consulting will gain access to expertise in device products/processes, design control and validation that will help them implement efficient, streamlined and cost-effective manufacturing processes while achieving optimal quality and regulatory compliance, which includes a global network of 80 expert consultants with experience in FDA, International Standardization Organization, good automated manufacturing practice, Health Insurance Portability and Accountability Act and Sarbanes-Oxley standards and regulations.

Services offered via the Avarent acquisition include: product/process development, delivery and commercialization; regulatory submissions; unique device identifier; quality management system development commissioning, qualification and validation; and project management multiple cross-functional teams. 

Avarent clients will gain access to NSF International’s team of experts in the regulatory, scientific, analytical testing and compliance fields to bring medical devices to market and sustain them throughout their life cycle. NSF Medical Device Consulting assists companies in navigating U.S. and international regulatory hurdles from product inception through product marketing. 

NSF’s current medical device services include quality systems implementation, remediation and auditing services; regulatory and clinical strategy consulting for medical devices including in-vitro diagnostics and combination products; clinical and biological evaluations; and good laboratory practice and good manufacturing practice contract laboratory services, such as extractables and leachables testing, clinical and non-clinical bioanalysis, oligonucleotide analysis, biocompatibility testing and toxicological risk assessments. NSF’s medical device team also provides quality and regulatory training courses.