Search Results
CMC002 - Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel
Vol 21 - Regulatory Starting Materials for API Drug Substance: Defining RSMs & FAQs in Development
ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials
Episode 20 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke
CMC003 - Effective Strategies for Early Stage Drug Development - Judy Magruder
Regulatory Starting Materials Designation in Drug Development
Episode 13 – A Discussion on CMC Strategy and Submissions with Ed, Brian & Meranda
Accelerated Approval Pressures Starting Materials
Understanding Differences Among Global Regulatory Jurisdictions
Which Regulations Impact CMC The Most?
Episode 14 – Why now is the most important time for selecting a CMO
Drug Substance Facilities – Hidden and Critical Intermediate
