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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.
To learn about our other service offerings, click
here.
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