Due Diligence Case Study

QMS-Compliance
CHALLENGE:
A large multi-national pharmaceutical company determined that the best strategy for a major pain-relief product was to expand associated synergistic product offerings. One product was a medical device from a small device company whose device applied a magnetic field with claims to alleviate pain and reduce inflammation. Targeting the company for acquisition the pharma company had performed an assessment of the clinical data but quickly recognized the need to address some resource gaps in the due diligence team. Lacking technical engineering, quality and medical device regulatory expertise, AlvaMed was recruited to support the team.


APPROACH:

AlvaMed proposed a 4-person team comprising the following expertise:

  • Quality
  • Regulatory
  • Clinical
  • Engineering

AlvaMed was approved for a 3-month $85,000 project that included

  1. 3 visits to the target company
  2. Multiple visits to the client to work with the team
  3. Technical research to assess the technical veracity of the claimed benefits
  4. In depth review of company filings and regulatory submissions


RESULTS:

In retrospect AlvaMed was most likely contracted because the client company had already detected some inconsistencies in the target company’s business and needed an unbiased assessment. AlvaMed quickly highlighted inconsistencies and also uncovered FDA communications that highlighted a very tenuous relationship with FDA.

In short-order AlvaMed uncovered the facts, confirming the suspicions of the team. The client team additionally requested AlvaMed to present our findings to the company “pain management” senior management. Our findings and communication was praised for being more informative and measured than any prior efforts from major consulting companies such as Quintiles and Deloitte.

The results of AlvaMed’s efforts on this project prevented major pain at our client.