My name is Edward Narke. In 2006, I co-founded Design Space InPharmatics to provide integrated CMC Drug Development and CMC Regulatory services to emerging pharmaceutical and biotechnology companies. We are blogging so that our Subject Matter Experts can keep you up-to-date with all of the latest news and excitement taking place in our industry, and for our friends, colleagues, and clients to have a say in that news.
Since regulatory is an experience-based profession, success is guided by one’s ability to learn from multiple experiences across various projects at different stages of development, which provides an understanding of basic principles that can then be applied to the decision making required for a specific project. Welcome to the our Blog.
Here you can find a collection of informative, interesting and entertaining articles and postings on a range of topics relating challenges and advances in development that can facilitate discussions of the basic Scientific and Quality issues that impact the overall drug development plan. Please contact me at firstname.lastname@example.org if you have any queries or comments.