Regulatory issues commonly arise in litigation including understanding FDA regulatory processes and review practices, labeling requirements, measures to assure safe use of products, manufacturing compliance, and detection analysis of safety signals.
NDA Partners LLC provides expert witness and legal assistance services, which are dedicated to providing informed advice to our clients. NDA Partners' areas of expertise span most fields of drug, biologic, generic, device, and diagnostic product development and FDA and EMEA regulations.
Our services include research and preparation of background documents, expert reports and court room testimony.
NDA Partners is focused on providing highly qualified and credible experts to attorneys and their clients. NDA Partners, Principals and Premier Experts are experienced in providing expert witness support for regulatory, product liability, and intellectual property/licensing disputes. NDA Partners can also provide in-house expert witness training.
NDA Partner experts have held senior level management positions with the Food and Drug Administration and/or within the pharmaceutical and medical device industry, and rank at the top of their fields. Our experts are published in leading medical, scientific and review journals, and are leaders and innovators in their respective fields.