CMC and 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.