New World Regulatory Solutions (NWRS) has seasoned professionals with decades of combined experience in regulatory, clinical, quality and technical affairs in the medical device and in vitro diagnostics industry. We provide superior, custom-tailored strategies for you to successfully bring your diagnostic innovations into the US healthcare market. NWRS can handle all the technical, regulatory, clinical, quality and compliance issues necessary for US market clearance. We also help US companies achieve ISO and CE mark compliance for the international market.

MISSION

New World Regulatory Solutions, Inc. (NWRS) was founded in 2002 with the mission of helping domestic and international companies gain regulatory approval for innovative medical devices. The company's team of professionals offers decades of collective experience spanning regulatory affairs, FDA and ISO compliant quality systems, clinical trials management, product development and technical and scientific affairs. NWRS embraces a total life cycle approach to product development and risk management to provide sound guidance and hands-on support from the concept stage through development, commercialization and post market issues.

SERVICES

NWRS' expertise encompasses FDA pre-market notifications including protocol development, Investigational Device Exemptions (IDE), 510(k) submissions and premarket applications (PMA), CLIA waiver petitions, quality system management for GMP compliance, CE marking and ISO certification, risk management, labeling and advertising, complaint handling, post marketing surveillance, recalls, vigilance and adverse event reporting, product and establishment registrations and laboratory studies. NWRS conducts and monitors clinical trials and prepares 510(k) and PMA submissions for class II and III devices, and we have taken companies through successful notified body audits for CE mark, ISO 13485, and CMDCAS certifications. The NWRS staff takes pride in providing immediate and personalized attention to our clients, and we are sensitive and responsive to deadlines, details, and budgets. NWRS offers competitive rates by minimizing overhead.

PERSONNEL

The NWRS staff consists of success-oriented individuals with senior level backgrounds and proven track records in the professional and home-use in vitro diagnostics industry. The staff's professional careers include experience at entrepreneurial start up and publicly traded fortune 500 companies. NWRS staff members have served on industry trade organization committees that help establish regulatory policy in the diagnostics industry. NWRS' combined years of experience in the diagnostics industry has been rewarded with the opportunity to work alongside the world's leading experts in the medical, scientific, regulatory and clinical arenas.

  • Key Personnel Include:
    • Maureen Garner, MS, MT (ASCP), ASQ CQA, President
    • Glenn Neuman, MS, Director of Scientific Affairs
    • Suzan Fenichel, MT (ASCP), Manager, Regulatory/Clinical
    • Katrina Fiedler, BS, ASQ CQA, RAPS RAC-US, Director, Quality System/Compliance

Maureen, Glenn and Katrina worked together for over 10 years at Carter-Wallace, a pharmaceutical, OTC, medical diagnostic products company, combining their regulatory, compliance and technical expertise, which is favorably received by regulatory bodies. Glenn and Maureen's strategic skills have produced industry firsts in CLIA waiver status for rapid point-of-care tests for mononucleosis and Lyme disease. Maureen was also instrumental in gaining the first sooner than missed period claim for a widely distributed OTC pregnancy test, which helped to double the brand sales in 2001 and moved the product to the #2 pregnancy test on the market with a 12.3% market share. Katrina has extensive experience and a successful track record in custom-designing, analyzing, auditing Quality Systems for FDA/QSR and ISO compliance, international product registrations/licensing/CE marking, and in global post market surveillance compliance matters ( e.g. complaint handling, recalls, medical device/vigilance reporting).

Maureen and Suzan worked together for a total of 5 years at two different start-up in vitro diagnostic companies specializing in POL and point-of-care medical devices intended for laboratory professionals and lay users, where they concentrated their efforts in building up and expanding the Technical Services and Training departments.

Maureen, Glenn and Katrina are active members of the Regulatory Affairs Professional Society (RAPS) and the American Society for Quality (ASQ), Association Medical Diagnostic Manufacturers (AMDM), and Maureen served on the In-Vitro Diagnostics and CLIA Task Forces at AdvaMed. Katrina is RAC-US certified and both Katrina and Maureen are ASQ Certified Quality Auditors.

There are many aspects to successful market entrance for new diagnostic tests. Any device that successfully passes through the US FDA pre-market review was designed to meet that goal. NWRS experience with the FDA has resulted in a proven record of success in obtaining device approvals and granting of CLIA waiver status for our clients' products.