Problem Statement
Client: An investment company was interested in making an investment decision for a Biopharmaceutical company and needed quality assessment to understand regulatory compliance risks associated with the company’s product portfolio and the several manufacturing facilities. The client needed Analytical and Quality experts to assess the company.
Expertise And Solutions
The client company hired us to conduct a due diligence assessment of the company with multiple manufacturing sites. A team of two senior quality and regulatory experts was assigned to conduct the due diligence assessment. We prepared an assessment plan and developed a list of documents to be reviewed as part of the assessment. The document list was sent to the client before the on-site assessment. During the site visit, we conducted tours of all the manufacturing facilities to understand the risks associated with facilities. We also reviewed all the product-related regulatory documents to understand the risks related to the company’s product portfolio. Daily updates related to risks were provided to the client. The assessment was completed within one week. All the associated risks were presented to the client. Based on the product and facility review, a final assessment report was also generated that included the company’s benchmarking against the industry. The report was submitted to the client on time.
Results And Feedback
As a result, the client was able to receive the information needed to make the investment decision. The client thanked us for completing the assessment and providing the report in a timely manner.