Due Diligence Audits for Acquisitions

  • Overview
  • Benefits
  • Why Work With NSF?

Our executive management team and expert consultants conduct numerous types of due diligence audits of pharmaceutical, biologics and biotech companies from start-ups to large, multisite companies to support acquisitions and investments. Our clients include law firms, venture capital and investment firms, industry partners and others. We perform due diligence audits to assess products and companies in all stages of development through commercial production. We can cover all aspects of regulatory compliance (regulatory strategy to cGMP and quality system compliance) and provide sound, scientifically-based advice to potential investors and purchasers.

Benefits

We can offer expert advice, assessment and evaluation to support acquisitions. Our team of former FDA employees and industry executives brings unique and invaluable perspectives and a deep understanding of regulatory considerations to the pharmaceutical, biologics and biotechnology industries.

Why Work With NSF?

This case study provides a real-world example of how working with us can help your company.

Challenge: We were called to help implement a new vendor assurance system. Our experts found that purchasing could place orders from unapproved suppliers without QA being aware of changes until the consignment arrived. An audit of suppliers revealed considerable quality risks and that unapproved materials were used in formulations, resulting in 20 percent of products being held in quarantine pending QA. This process posed quality and financial risks to the company.

Solution: After conducting a full review of the current processes, we helped the company install an end-to-end process for introducing new suppliers (pending, approved and certified), aligned to GMP and business needs. We also helped build relationships and awareness of roles across QA, planning, operations and purchasing, and increased shared success through mutually agreed-upon objectives. As a result, no products were held in quarantine pending QA due to vendor-related issues.

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