NAMSA started in 1967 when a glass manufacturer in Toledo, Ohio approached a clinical lab to test polymeric materials for pharmaceutical container testing. The clinical lab passed, but a scientist-entrepreneur took the project on, following methods outlined in the United States Pharmacopeia. Soon thereafter, Science Associates was born, and testing expanded to medical devices and materials. In 1976, Congress authorized FDA (The Food and Drug Administration) to regulate medical devices, and North American Science Associates, Inc. had already been testing such products for 10 years as a contract research organization (CRO). Regulations continued to evolve and become more complex, and NAMSA has been an integral part in developing domestic and international standards for testing medical devices, materials and combination products for the last 50 years.
Today, in addition to laboratory testing, our services have grown to include expert regulatory, clinical, and compliance services. We have also been active in educating our Associates as well as our clients about industry regulations and best practices. These additions have helped NAMSA become more than a contract research organization; we became a medical research organization (MRO). At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.
Our timeline tells the story of how we’ve grown.
Dr. Theodore Gorski, a scientist-entrepreneur, founded Science Associates. This company was incorporated to test materials used in medical devices and pharmaceutical containers.
Sportol® biological indicators were developed. These indicators were the first of many in a line of sterility assurance products.
The name Science Associates was changed to North American Science Associates, Inc. (NAMSA) when Dr. Gorski and his wife, Mrs. Lucille Gorski, assumed full ownership of the company. NAMSA then moved to its current corporate headquarters located in Northwood, Ohio.
The Medical Device Amendments to the Food, Drug and Cosmetic Act gave FDA authority to require that medical devices be shown safe and effective before being used in hospitals and clinics.
NAMSA expanded to Irvine, California to allow for same-day release testing.
Substantially informed by NAMSA’s biocompatibility matrix, the Tripartite guidance was introduced by an FDA official at a NAMSA seminar. This document formed the basis for ISO 10993-1.
We acquired McMillan Research in Kennesaw, Georgia.
NAMSA purchased Biomatech in Chasse-sur-Rhone, France, to expand our international presence. Biomatech provides NAMSA with over 18 years of laboratory and consulting services.
Developed and sold RSI product line of rapid read-out sterility indicators.
Completed the first phase of a 14,000 square-foot expansion plan in Northwood, Ohio, including a new vivarium, toxicology laboratory and administrative building.
NAMSA introduced its consulting practice engaging clients earlier in the product development process.
Acquired Ceetox, offering in vitro toxicology screening tools to reduce, refine and replace the use of animals in testing health care products.
Completed the second phase of the expansion plan in Northwood, Ohio, including a 10,000 square-foot surgical center and a 15,000 square-foot addition to the toxicology facility.
Acquired Alquest, a leading medical device and biologics CRO, specializing in regulatory, clinical research and quality support. Alquest provides NAMSA with over 20 years of laboratory and consulting services.
The Integra Group, an accomplished company with unique preclinical to clinical services and research study know-how, was acquired. They provide NAMSA with over 10 years of laboratory, clinical and consulting experience.
NAMSA completed the third and final phase of the expansion at the Northwood, Ohio facility. This was the 10th overall expansion of the facilities in as many years.
NAMSA acquired Medvance Ltd located in the United Kingdom to expand our clinical and consulting capacity across Europe. Medvance provides NAMSA over 10 years of clinical and consulting experience.
NAMSA opened a new 80,000 sq. ft. preclinical research laboratory in Shanghai, China in October 2016, representing NAMSA’s third Asian-Pacific location and its commitment to helping clients efficiently bring life-saving medical device technologies to the APAC marketplace.
NAMSA, recognizing increased demand for analytical testing services within Germany–Europe’s largest medical device market–launched its ISO 10993-18 testing laboratory in March 2018. Located in Obernburg, Germany, NAMSA’s analytical services lab offers exhaustive extraction, FTIR, GC-MS, LC-MS and ICP-MS capabilities for European medical device manufacturers.