Regulatory Affairs

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert at DS InPharmatics and is very technically proficient in all aspects of analytics. In this episode, Ed, Brian, Meranda and Colman expound on the process of analytical method development, including challenges, physiochemical properties that can impact the process and regulatory parameters and agencies that exist.

Les Mintzmyer is a Sr. Biologics Manufacturing Consultant at Design Space InPharmatics. Today, Les joins the show to share his experience as a leader in the field of bio-pharmaceutical manufacturing. In this episode, Ed, Brian, Meranda and Les break down the Request for Proposal (RFP) process including three critical factors: verification, qualification and validation. Les speaks to best practices for identifying and selecting the appropriate Contract Manufacturing Organization (sometimes referred to as CMDOs) to partner with.

Dave Adams is a Senior Drug Substance Consultant at Design Space InPharmatics. Today, Dave joins the show to share his experience solving problems in active pharmaceutical ingredients (APIs). In this episode, Ed, Brian, Meranda and Dave discuss the importance of comprehensive development programs. Dave speaks to quality assurance, tech transfer procedures and real-world case studies that he has encountered throughout his career.

Edward Narke is a Principal and Regulatory Managing Director and Brian Lihou is the Head of Operations at Design Space InPharmatics. Today, Ed and Brian join the show to share their collective experiences in filing for an Investigational New Drug and a New Drug Application. They break down the concept of ‘rest-of-world awareness,’ the importance of storyboards and timelines for document submission.