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VC: We performed due diligence for a Venture Capital firm looking to invest in a pre-clinical start-up. We did an in-depth SWOT analysis on Manufacturing, Technical and Quality systems. Our presentation provided a succinct summary on key areas the VC needs to focus on to ensure that the start-up avoided major pitfalls.
 
Overflow: An NDA was under review by the FDA. The sponsor needed resources from Regulatory Affairs and Product Development to review proposed responses to agency questions. We provided support until the surge demand dissipated.
 
Set up systems: A start-up was making the transition from pre-clinical to clinical stage. We set-up Quality systems that were phase appropriate; helped prepare the IND submission and provided recommendations on possible Contract Manufacturing Organizations (CMO) that were a good fit for the start-up.
 
Outsource for cost efficiency: A company was preparing to manufacture a series of lots at a CMO in support of a submission. To preserve cash, the company asked us on as-needed basis to provide Quality, Analytical and Manufacturing oversight to the organization. We provided a complete solution from creating documents to overseeing batch manufacturing and testing through to release of the product.
 
Independent Review: Our sponsor was compiling their NDA for submission to the agency. They called us in to provide an independent review of the application for accuracy, completeness and consistency of messaging prior to submission.
 

 

 
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