Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging diagnostic companies. The following case studies describe specific solutions that we have tailor-made for our diagnostics company clients.
- Challenge: A leading global pharmaceutical company contracted Beaufort to assess and re-validate their manufacturing equipment cleaning process.
- Challenge: An international pharmaceutical corporation engaged Beaufort to assess the entire validation process for a recently acquired global business unit.
- Challenge: A global medical device corporation engaged Beaufort to evaluate the validation status and performance of a purified water system of a recently acquired manufacturing unit.
- Challenge: A large manufacturer of pharmaceutical products engaged Beaufort to develop a new distribution strategy to accommodate growing complexity in its supply chain resulting from the implementation of a new sterilization process of its primary packaging materials.
- Challenge: An international pharmaceutical corporation engaged Beaufort to evaluate its options for implementing an enterprise resource planning (ERP) solution for a recently acquired global business unit.
- Challenge: A leading global pharmaceutical company contracted Beaufort to validate its packaging process using our proven process analysis approach and tools to facilitate the implementation of a new vision and optical character recognition system.
- Challenge: The US Subsidiary of a Large, International Pharmaceutical Company Needed Assistance in Preparing for Several Regulatory Inspections
- Challenge: A venture-funded European biotechnology company needed a regulatory strategy for a combination device-biological CNS product.