Compliance and Integrity Programs

  • Overview
  • Why Work With NSF?
  • Success Stories
  • Services
  • Experts

The Compliance and Integrity Programs team at NSF Health Sciences provides a broad range of practical compliance solutions for clients in the pharmaceutical, medical device and biotechnology industries. Our team of subject matter experts is comprised of seasoned compliance executives and former senior management personnel at the FDA and at pharmaceutical and medical device companies of all demographics. We have nearly a decade of Corporate Integrity Agreement management experience as well as pre- and post- enforcement action compliance program strategies to support large and small initiatives alike.

Our professionals have also worked closely with dedicated federal monitors at the HHS OIG, boards of directors and cross-functional senior leadership, providing a unique perspective to our advisory services. At NSF Health Sciences, we understand that each company has unique needs, resources and structure. We work closely with our clients to develop tailored solutions that satisfy the compliance and business unit objectives of your organization.

For more information about NSF Medical Devices compliance and integrity programs in the U.S., email medicaldevices@nsf.org or call +1 202.822.1850.

For more information about NSF Medical Devices compliance and integrity in Europe, email eudevices@nsf.org or call +44 1143 600 868.

Why Work With NSF?

Partnering with NSF for compliance and integrity services provides the following benefits:

  • NSF staff includes former FDA regulators and industry experts who leverage their experience to assure alignment with FDA expectations.
  • We provide proven methodologies and a record of success with complex quality and regulatory issues.
  • Our expert advice and guidance assures your company becomes self-sufficient with ownership of the enhanced system.
  • Our detailed knowledge of industry best practices assures practical, doable systems.

Our total product lifecycle approach embodies the concepts of a quality system by establishing links between phases and capturing feedback throughout the lifecycle.

Our experts have regulatory backgrounds or experience in the medical device industry. We are committed to providing the highest quality services based on sound science, risk assessment and common-sense, pragmatic solutions to help you achieve your goals.

Success Stories

Challenge: A Class II medical device manufacturer entered into a Corporate Integrity Agreement requiring five annual systems reviews by an Internal Review Organization to evaluate its compliance with the agreement.

Solution: NSF Health Sciences Medical Devices supported the Corporate Integrity Agreement (CIA) obligations as the company's Internal Review Organization (IRO). Through NSF’s evaluation and recommendations for improvements to clinical, regulatory and quality systems processes and operations, including labeling, promotion and advertising practices, the company satisfied its obligations under the CIA.

Services

We offer a broad range of compliance program services across all sectors of the life sciences industries, including:

  • Development and implementation of oversight support for effective compliance programs
  • Training on U.S. health care programs fraud and abuse prevention and compliance with industry codes of conduct (PhRMA, AdvaMed, EFPIA)
  • Compliance auditing and monitoring for commercial, clinical and post-market activities
  • Compliance program assessments and operational enhancements (gap analysis)
  • Code of conduct and ethics development and enhancements
  • Corporate Integrity Agreement (CIA) & Deferred Prosecution Agreement (DPA) support
  • Independent Review Organization (IRO) and pre-IRO services
  • Board of directors compliance expert services
  • Internal investigations of alleged compliance violations; provide key support for continuity and focus during government-led investigations
  • Contracting and interactions with health care providers
  • Promotional materials and concept review for advertising activities
  • Compliance with global and domestic transparency reporting requirements
  • Temporary professional staffing support to address emergent needs

Experts

Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices.

Katherine C. Norris, MPA - Senior Director, Compliance & Integrity Programs

Ms. Norris has over 10 years of experience in corporate governance and compliance in the pharmaceutical, medical device, OTC consumer products and cosmetics industries. She has performed substantial internal investigations and supported extensive federal investigations with multiple agencies, including the United States Department of Justice, Health and Human Services Office of Inspector General and the Securities and Exchange Commission. Ms. Norris assists clients with internal and external investigations, remediation of cross functional compliance concerns (including implementation and compliance with CIAs and DPAs), and the operational aspects of compliance program development, management and oversight, including aggregate spend initiatives.

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