CMC & Bioanalytics

How can I optimize the bioavailability of my drug?

How can I improve the COGS and production timelines for my clinical trial material?

How can I ID the active metabolites of my drug?

How can I optimize the solubility of my compound?

Do I have enough safety information for my compound so that my potential contractors will provide realistic and accurate quotations?

I have a highly potent agent for development. Will that raise my contracting costs? Will it limit responses from the market?

We’ve only made a couple of grams of our compound so far for our studies, but it looks really pure. When FDA says my compound has to be “well-characterized”, what do they really mean?

Our compound isn’t hard to make. What kind of lead time can I expect from my contractor to make more material?

How do I make sure that what my vendors develop will pass muster with regulatory authorities?

How do I plan my clinical trial supplies to that I don’t run out, but I don’t waste a lot of money?

Example of solutions to address the above questions

  • Create development and regulatory strategies for drug substance and drug product
  • Develop a comprehensive bioanalytical program to streamline development processes
  • Troubleshoot method development, stability issues
  • Prepare and review regulatory submissions
  • Assess bioanalytical expertise in contract manufacturing organizations
  • Provide scientific interpretation of manufacturing and analytical results
  • Provide recommendations for setting specifications and product shelf-life