Negotiations between corporate entities and other
organizations often require the services of outside
experts to review critical information and plans to
ensure a factual basis for merger, acquisition,
investment or other contractual agreements. Our
firm supplies such expertise in the areas of
pharmaceutical and biopharmaceutical manufacturing and
manufacturing related regulatory review. In
addition we assess the suitability of cell based
technologies for scale-up and commercial manufacturing.
We have performed these services for a number of
organizations. The due diligence procedure generally
involves the following steps during an on-site meeting
and/or by review of electronic documents:
Review of CMC
(Chemistry, Manufacturing and Control) sections
of INDs, BLAs and NDAs.
Review of other
regulatory submissions and amendments related to
Review of company /
FDA interactions, including FDA meetings,
correspondence, inspection reports, etc.
Review of the
manufacturing technology and its suitability for
cost effective commercial operations.
involving cell based therapies, e.g. gene
therapy, cell therapy or stem cells, we review
the scientific research and development programs
for their potential to lead to products that are
feasible for commercialization.
whether any significant, undisclosed "road
blocks" exist (associated with manufacturing
issues) to the goals of the agreement between the
Following the review of
documents and the on-site meeting, we prepare a report
with our assessment of the manufacturing program and its
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