Designing an adequate nonclinical program to support the safety of cell or gene therapy products is not always straightforward. In this blog, we will address common questions we receive from our clients and aspects to consider when designing those nonclinical studies. In which species should the toxicity study be conducted? Does it have to be…
Expertise: Consulting 41 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 is a must for placing products on the market. With the implementation of the EU…
Consulting
Madelyn “Mimi” Huang, Ph.D.
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 multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical plans for…
Consulting
Will Bainbridge
Consulting