Regulatory Strategy and Compliance Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging biopharmaceutical and biologics companies. The following case studies describe specific solutions that we have tailor-made for our biopharmaceutical and biologics clients.
A start-up biotechnology company needed a regulatory strategy designed to reposition a previously withdrawn compound. Founded by an academic physician, a chemist, and a business person, the company had a clear vision regarding its business objectives but lacked the expertise necessary to navigate the FDA regulatory maze. As a result, its initial in-house orphan disease application was rejected by FDA. Realizing its need for experienced guidance, the company engaged Beaufort to develop a comprehensive regulatory strategy taking the compound’s history into consideration. Beaufort prepared a new orphan drug application, which was cleared in one review cycle. Beaufort also provided ready-to-use information for investor and academic presentations. Since engaging Beaufort, the company has increased fundraising, cleared an additional orphan drug application, and is proceeding with a sound regulatory strategy.
A venture-funded European biotechnology company needed a regulatory strategy for a combination device-biological CNS product. The company’s product had demonstrated significant promise based on animal and theoretical models. However, it needed guidance in getting to the first stage of the IND/IDE process. The company engaged Beaufort to support this development. Beaufort worked with management to assess existing and potential competitive products and to determine which of the potential indications should prove most valuable. Our work included a regulatory strategy for optimally approaching the IND/IDE stage of product development with the result that the client now has a detailed plan with a streamlined set of possible indications.
An established, privately-held European company wanted to introduce its products in the North American market. Before engaging Beaufort, the company had been advised that it would be unable to register a major product in the United States. Beaufort worked with senior management to consider regulatory alternatives including a switch to cGMP-compliant manufacturing. As a part of the process, Beaufort provided a thorough review of all documents related to the company’s products, inspected its plant and other operations, and trained employees regarding regulatory process and criteria for submissions. As a result, the client passed a Health Canada regulatory inspection, won approval for its product in Canada, and is on the road to full cGMP compliance with an IND pending with FDA.
A European company focused on the development of oncology vaccines needed assistance in planning for a US IND, as well as a global Phase II clinical program. Beaufort designed an IND strategy that addressed the challenges facing an oncology vaccine, while taking into consideration the problems faced by other companies with similar compounds. Beaufort provided CMC support for the client’s manufacturing efforts. In addition, Beaufort consulted on and prepared the Pre-IND package for the FDA. The client received such a clear positive response to the package that a meeting with the agency was deemed unnecessary. This process facilitated the near-term development of their compound and led the way for the international Phase II program.
