The FDA's January 2020 guidance, Chemistry, Manufacturing and Control (CMC)[1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics. The analytical package, consisting of...
Expertise: Consulting 206 results
CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark...
In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval....
Consulting
Madelyn “Mimi” Huang, Ph.D.
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect safety and effectiveness data.[1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This...
Consulting
CMC Considerations for Pre-IND Meetings
The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics. In general, such meetings are...
“Artificial Intelligence (AI) and Machine Learning (ML) as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. ML is considered a subset...
Consulting
Will Bainbridge
MORRISVILLE, N.C., October 9, 2023 — Premier Consulting, a business unit of Premier Research whose mission is to help the most innovative companies take their best ideas from concept to commercialization, is pleased to announce the appointment of William Bainbridge...