Performing regulatory due-diligence for a successful medical device acquisition. PROJECT TITLE. CLIENT. SERVICES PROVIDE
CASE STUDY PROJECT TITLE
CLIENT
Performing regulatory due-diligence for a
Leading In-Vitro
successful medical device acquisition
REGION
BACKGROUND
A medical devices company encountered the opportunity to acquire their first technology license and needed to understand their different regulatory compliance obligations prior to acquisition. The technology has been used for years globally, thus there was a large amount of clinical data related to the acquisition
Diagnostics manufacturer
Taiwan / Europe
SERVICES PROVIDED Regulatory Services Quality Compliance Market Research Licensing & Acquisition
of the license.
PROBLEM
The company was unable to properly evaluate the scientific data and comply with the regulatory obligations; making it difficult to decide if it would be cost-effective to acquire the technology and at what price.
OUR SOLUTION Using our due diligence and technical experts, Biomedic Consulting was able to help the company navigate through all the regulatory obligations and supported the decision to acquire the technology license effectively. Biomedic Consulting worked closely with the scientific staff at the licensor company to identify all the risks related and create an exhaustive risk report. Biomedic Consulting analyzed the large amount of data and coupled our business experts to evaluate the commercial benefits of acquiring the license.
RESULTS Biomedic Consulting successfully advised the company in its decision to acquire the license. The company was able to negotiate a better price for the license acquisition. The acquisition of a EU license was negotiated in order to provide a wider access to the European market.
For more information about Biomedic Consulting services, contact us at
[email protected] or visit us at www.biomedicasia.com
