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