Since 1996, The Anson Group has tailored client-focused solutions that align project goals with overall business objectives. Looking at issues in the context of our clients’ resources and culture, our team of industry experts identifies available regulatory options and helps select the best pathway to success. Our areas of expertise include Drugs & Biologics, Medical Devices, Combination Products, Connected Health Technologies, and Technology Commercialization.
The Anson Group focuses on development of successful, long term client relationships and providing the highest quality professional services possible. We are committed to a singular mission; Enhancing the Value in Medical Technology our clients have developed for the improvement of human health and well being. For Anson professionals, our role in enhancing our clients’ product value means that we must first understand their underlying business objectives, and then provide the appropriate regulatory strategic, advisory, and execution services that are conceived, planned, and delivered to advance these objectives.
Anson offers a comprehensive range of services options necessary for every stage of product development, from early phase design and development planning, preclinical and clinical validation, and market approval and post-market compliance:
- During the product planning stage, we can help develop effective preclinical and clinical testing and market approval strategies. Additionally, we can help to anticipate and prepare for potential pre and post-market compliance issues.
- For clinical research, where FDA requirements for drug/biologics and medical devices diverge sharply, Anson can provide consultants and project managers with decades of specialized experience in all product areas.
- For submissions and product approvals, we plan and attend pre-submissions meetings with FDA to establish clear criteria for acceptance or approval, and then assemble submissions that meet those criteria. Members of our team interact regularly with the major FDA Drug, Device, and Biologics Centers, so that we understand what it takes to ensure a client has successful interactions with FDA.
- For post-market compliance Anson’s quality assurance and corporate compliance professionals focus on establishing, enhancing, and maintaining cost-effective quality systems that meet our clients’ quality business goals as well as FDA regulatory requirements.
For more information, contact:
Johna Carufel, Business Services Manager,
317- 569-9500, extension 117 (Telephone) 866- 521-9500
(Toll-free) 317- 569-9520 (Fax)
jcarufel@ansongroup.com (Email)
The Anson Group is a certified minority business enterprise, participating in both corporate and government diversity programs.
