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Case Study: Due Diligence Support

   

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Challenge

A large Pharma company looking to broaden their portfolio in a key business segment needed to quickly evaluate a promising new device technology, but lacked medical device knowledge and experience

Solution

AlvaMed’s team of medical device experts, totaling over 140 years of medical device experience, engaged in a comprehensive and balanced due diligence evaluation of the target company and its technology. Working closely to integrate our efforts with our client’s team, our team assessed all key opportunity factors including:  technology effectiveness/clinical results, FDA and regulatory strategies, quality systems and compliance, intellectual property strength, and manufacturing/ supply chain capabilities.  A detailed report delivered within 3 weeks after visiting the target company summarized key findings and path forward recommendations.

Results

Our final presentation to our client’s senior management outlined the investments necessary to address key gaps and a development plan and negotiating points to address the major risks. Described by our client’s senior management as the “best ever due diligence effort in terms of attention to detail and clarity/relevance of communication” our client’s senior management few questions and quickly supported the team to take the next step of negotiation.

More information

Gap Analysis

Reg. Pathway Strategy

Mfg/Supply Chain Assess.

 Mark Cox
 President

 

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