Edward Narke is the Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at DSI. In this episode, Ed and Meranda discuss topics they’ve covered previously on DSI’s ongoing blog series, The Regulatory Odd Couple.
They dive deep into the process of regulatory drug development, including the importance of having justification for regulatory starting materials, how to convey the sweet spots of your process, secrets to building the quality overall summary, and the role that excipients play.
Ed and Meranda also share their thoughts on the considerable latitude for assimilating, discussing, comparing, and contrasting data that is allowed and even encouraged.
There are opportunities to be creative, to tell a story, and to craft cohesive arguments to help regulatory bodies understand your product.