Get to market. You want to develop medical devices that are safe, effective, and compliant. We ll show you the most efficient path.

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1 Get to market. You want to develop medical devices that are safe, effective, and compliant. We ll show you the most efficient path. Clinical Research Services

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3 We ve been the world s leading medical device research organization for over 40 years. A science out of service. You want sound advice and action from a partner who can quickly move your product into a global market. So we ve made a science out of service, identifying challenges and solving them with the right advice at exactly the right time. We can guide and support you through the most complex submissions and the most rigorous testing programs. We do the work that moves things forward quickly without ever compromising quality. And our passion for scientific integrity gives you the security that you re on the optimal path to market, anywhere in the world. At NAMSA, we have a lot of success to share.

4 We founded an industry on our values and we re still growing. The values that defined us in 1967 are the same values that guide us today. We perform high-quality, honest work. We sell only what you need and no more. Our results and services are timely. We fulfill all regulatory obligations. We treat our Associates with dignity and respect. We re smart about our financial resources. And above all, we always conduct ourselves with integrity.

5 You can see our values in everything we do. We are your trusted partner in product development.

6 The NAMSA Story 1967 scientist-entrepreneur Science Associates is founded by Dr. Ted Gorski,a a scientist-entrepreneur, to test materials used in medical devices and pharmaceutical containers same-day release testing Expanded operations to California to allow for same-day release testing market appeal Developed and sold the RSI product line of rapid read-out sterility indicators new campus: phase two Completed the second phase of the expansion expansion plan in Northwood, plan in Northwood, Ohio, including Ohio, a including 10,000- a square-foot 10,000 ft. 2 surgical center and a 15,000- ft. 2 addition square-foot to the addition toxicology the facility toxicology facility sterility assurance Developed Sportrol biological indicators, thefirst indicators, a the line first of sterility in a line assurance of sterility products assurance products advancing the industry Substantially informed by NAMSA s biocompatibility matrix, the Tripartite guidance was introduced by an FDA official at a NAMSA seminar. This document formed eventually the formed basis for the ISO basis for ISO new campus: phase one Completed the first phase of a 140,000- ft. 2 expansion square-foot plan expansion in Northwood, plan in Northwood, Ohio, including Ohio, a including new vivarium, a new toxicology vivarium, toxicology laboratory, laboratory, and and administrative building building clinical expansion Acquired Alquest, a leading CRO, medical device and specializing biologics CRO in management specializing in of regulatory, clinical trials clinical research, and quality support.

7 1971 corporate headquarters North American Science Associates moves moved to current the current Tracy Tracy Road Road facility facility industry regulation FDA mandated pre-market approval of medical devices domestic growth Acquired McMillan Research in Kennesaw, GA global expansion Purchased Biomatech in Chasse-sur-Rhone, Chasse-sur-Rhône, France, to expand NAMSA s international presence advisory services NAMSA introduced its consulting practice, engaging clients earlier in the product development process new technology Acquired Ceetox, offering in vitro toxicology screening tools to reduce, refine, and replace the use of animals in testing health care products.

8 We bring strategic insight to every stage of the product development process, in any part of the world. Regulatory and Quality Systems Consulting Research and Development Support Non-Clinical Testing Clinical Research Post-Market Support NAMSA services were designed specifically around the path to market. That means we can support you no matter where you are in the process. What sets a NAMSA relationship apart? Close collaboration with you in bringing your product to market. We re invested in knowing your product inside and out, and we re as committed to its success as you are. We ve built our services, and our entire way of working, around taking you and your product from start to finish no matter how long or complex the path to market may be. We anticipate challenges. We solve with confidence and creativity. We give the right advice at the right time. We deliver only what you need. We stay the course.

9 We strive to meet your needs from start to finish, with speed and uncompromised quality. Regulatory and Quality Systems Consulting The regulatory landscape is complex. We work with you to develop and execute successful regulatory strategies in any part of the world. We offer: regulatory strategy and submission support quality systems design and implementation functioning as a virtual RA/QA department emergency response to agency concerns, warnings, or decisions on-site staffing ad hoc hourly consultation and advice Research and Development Support Developing new products can be a lengthy and expensive process. We ll help you make it as efficient as possible. We can assist you with: characterization of materials and analytical chemistry risk assessment and mitigation biological safety evaluation plans method development and validation services efficacy and performance studies Non-Clinical Testing When it comes to non-clinical testing, you can rely on our safety evaluation studies (in vitro and in vivo) on a variety of biomaterials, medical devices, and related products. We offer: in vitro and in vivo toxicology services histopathology services Clinical Research Our clinical experience encompasses a broad range of technologies, therapies, and indications. Our focus on devices gives you the best in: clinical trial design trial management and monitoring data management and biostatistics feasibility, pivotal and health outcomes research global trial conduct Post-Market Support Your needs don t end at product launch. We can help with activities that happen after you hit the market: sterility assurance manufacturing environmental control manufacturing process control finished product qualification quality assurance release testing periodic audit testing ongoing regulatory consulting post-market clinical trials

10 Our process We match every step with your specific needs. We can apply time-saving strategies in specific segments or across the entire product development process. discovery What are your objectives? What are your timing and budget constraints? What s your risk tolerance? Your answers to these questions determine our course of action, whether that s to begin testing right away or to focus additional energy on planning. synthesis We identify which steps in the development process are most important for your product and which can be omitted. We look for obvious and not so obvious ways to shorten the path from concept to submission and then share our key findings with you. recommendations Finally, we provide tailored, comprehensive deliverables at each phase of the project, with clear understanding and communication of next steps.

11 We can tailor solutions for you. We work with you to develop individualized testing programs, whether we re guiding you through a simple test or a complex development project. We also provide guidance through the submission and regulatory approval process. The result for you: a shorter, simpler, and more cost-effective path to market. We are committed professionals. We believe the foundation of our success is our precise, intentional blending of valuable experience with world-class testing and advisory services and clinical experts. That s why we create teams of knowledgeable sales professionals, scientific experts, and regulatory and clinical laboratory staff who, by pooling their expertise, are equipped to deliver smart solutions and on-time results to you every time. We know the best way to communicate. Our technical specialists deliver reports and supporting data that are easy to understand, and present them in ways that are preferred by regulatory bodies. And we offer services to interpret test results and identify problems that may occur at any point during the product development process. We provide consultation throughout the product development lifecycle. We develop specific testing and clinical programs for your products and give you continued support through regulatory submission, defense, and approval.

12 People are our difference. We believe that a diverse workforce of well-educated, well-trained, and well-respected Associates can drive groundbreaking improvements in business operations.

13 So we invest in every member of our staff. We ask them to grow, and we provide opportunities for them to do so. We ve created a culture rooted in our values, and all of our operations are based on respect and innovation. Because we re driven for quality, we re big on deadlines and stringent regulations. We hire people who can be innovative within our strict scientific guidelines, and we value their work, their insight, and their gifts, with both respect and compensation. Our people are special. It takes a unique kind of person to balance rigor, innovation, and speed. That s exactly what we ask of our Associates and they come through for us, every day. WE CONSISTENTLY INVEST IN TRAINING AND DEVELOPMENT OPPORTUNITIES, LABORATORY SYSTEMS, AND OTHER PROCESS-BASED IMPROVEMENT TECHNIQUES.

14 A global presence: we offer support without geographic limits. Delivering a product to market can be a long process, even when you re familiar with the regulatory requirements. But when you face the unknown requirements of another country, the process can be even more complicated. We work as a trusted advisor to our clients, offering the best in consulting and testing services, helping them navigate regulatory pathways all over the world. Our technical staff understands the many compliance requirements of the U.S. Food and Drug Administration; European Notified Bodies; the Japanese Ministry of Health, Labor, and Welfare; the Chinese SFDA; and other regulatory agencies worldwide.

15 We understand your world. We have representatives across five continents to serve the global market.

16 Expectations: we ll take you further. At NAMSA, you can expect a commitment to scientific integrity and an unparalleled breadth of solutions. You can also expect strategic insight and expert implementation at every stage of the product development process, in any part of the world.

17 Even more, you can expect an efficient process. And in a crowded market with tight timelines, you know there s no room for error. Efficiency in product development is more important than ever, even as regulatory requirements become increasingly complex. Speed can often come at the cost of quality, and compromised quality can quickly take your product right back to the starting line. That s why having a smart strategy from the outset is so important and why we put it at the forefront of every project. We ve streamlined our operations from top to bottom. We can find ways to help you strike a balance between speed and quality, save money, and meet your objectives all at once. We re your trusted partner. And we ll take you farther.

18 Innovative. Reliable. And ready. We ve worked with thousands of companies to date bringing safe, effective, and compliant medical products to global markets through the most efficient processes available. We are passionate about our people, our scientific integrity, and the breadth of solutions we offer our clients globally. And we re ready. Ready to take you to market. Contact us: World Headquarters 6750 Wales Road Northwood, Ohio USA Telephone: (toll free) (outside of USA) (fax)

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20 World Headquarters 6750 Wales Road Northwood, Ohio USA Telephone: (toll free) (outside of USA) (fax) For more information and a listing of locations worldwide, visit North America Science Associates, Inc. 2011; Printed in the USA. XXXX.

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