Edward Narke is a Principal and Regulatory Managing Director, Brian Lihou is the Head of Operations and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed, Brian and Meranda join the show to share their collective experiences in the field of CMC. They dissect the process of filing for an Investigational New Drug (IND) and a New Drug Application (NDA), the concept of ‘rest-of-world awareness,’ and the importance of storyboards and timelines for document submission.