Preparing for regulatory submissions and interactions requires seamless communication and continuity across multiple disciplines. While many consulting companies offer regulatory project management as a capability, Premier Research Regulatory Project Managers (PMs) elevate the position by acting a single point of...
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Defined by the US Food and Drug Administration (FDA) as a strategic development process tool, the Target Product Profile (TPP) “embodies the notion of beginning with the goal in mind.”[1] Broadly, the TPP is a template that summarizes key drug...
On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for...
There are numerous reasons why a sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial benefits to the sponsor, providing a more convenient and/or faster-acting dosage form of a well-chosen drug...
Previously on this blog, we have explored the 2020 Chinese export ban on non-human primates (NHPs) and its consequences on pharmaceutical research. In that same post, we explored potential solutions to keep sponsor programs on track. In response to the...
On the path to U.S. commercialization, every pharmaceutical product makes a stop at the Food & Drug Administration (FDA). Whether that stop becomes a waystation or the end of the line may depend on the degree to which the presenters...
For developers of new drugs, the Common Technical Document (CTD) is the cornerstone of an Investigational New Drug Application (IND). The CTD is designed to harmonize the submission of data and information to regulatory agencies, reducing the time and resources...
The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences between 505(b)(1) and 505(b)(2)? Drug development pathways in the United States are referred to by their corresponding section in the Food, Drug,...
As we noted in a separate blog post, the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed...
One of Premier Research's differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Informed by today’s competitive drug development landscape, as well as by...