Wetzel Chemistry Consulting, LLC

Chemistry Leadership for Drug Discovery and Development

 

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Chemistry, Manufacturing & Controls (CMC) management

Timely, cost-efficient achievement of your development milestones requires that you consistently make good decisions. 

         Which of the dozens of available contractors should you employ to scale up your active pharmaceutical ingredient (API), formulate your drug, manufacture your clinical test material (CTM) and develop your analytical methods? 

         Is your existing API synthetic route suitable for scale-up, or should you spend money and time to develop a new one? 

         For what combinations of studies is it advantageous to use a single batch of API?

         What information and assurances will the FDA expect before they allow you to proceed with your proposed clinical trials? 

Avoid program delays and cost over-runs by asking for our guidance on questions like these before you begin preclinical development. 

If you simply need help in writing the CMC section of your IND or other regulatory filing, we have this expertise and will gladly help you meet your filing deadline. 

We can support filings in 21CFR312.23, CTD or eCTD format.


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