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Due Diligence
 

Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC

 

   

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:
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Review of CMC (Chemistry, Manufacturing and Control) sections of INDs, BLAs and NDAs.

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Review of other regulatory submissions and amendments related to manufacturing issues.

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Review of company / FDA interactions, including FDA meetings, correspondence, inspection reports, etc.

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Review of the manufacturing technology and its suitability for cost effective commercial operations.

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For programs 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.

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Determination of whether any significant, undisclosed "road blocks" exist (associated with manufacturing issues) to the goals of the agreement between the parties.

Following the review of documents and the on-site meeting, we prepare a report with our assessment of the manufacturing program and its regulatory status.

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