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...
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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...
Submission of an Investigational New Drug Application (IND) is a milestone in new drug development, marking the transition from bench research to clinical studies in human participants. Successful IND submission requires careful planning and strict compliance with regulatory requirements, which...
Knowing which products have verified profit potential before development begins helps defend their value to investors and reduces the risk of costly marketing errors. Working with a partner with extensive 505(b)(2) experience can offer the right process to identify products...
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,...
Morrisville, N.C., February 22, 2022 — Premier Research launched Premier Consulting today by consolidating two legacy brands within its portfolio — Regulatory Professionals, Inc. (RPI) and Camargo Pharmaceutical Services. Premier Consulting is a unified strategic product development and global regulatory consulting brand...
Regulatory approval is the final hurdle sponsors face when launching an in vitro diagnostic (IVD). After spending many years and millions of dollars on development, it can prove frustrating when the finish is in sight, but there are barriers to...