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According to Deloitte, only 24% of firms in this market claim that risk is fully integrated into their IT strategies, while “72% report that integration is still in progress. In contrast, only 9% of the organizations surveyed conduct risk assessments more frequently than once a year, while 46% perform them annually. Fifty-four percent of respondents assess risk on an ‘event basis.’”

In spite of this, regulators demand a lot of transparency and integrity, while not giving one whit about your strategic business goals. Of course, Zellerent can help you mitigate your risks and be prepared with the right evidence, should the regulators arrive at your doors. But we can do a lot more.

Zellerent’s Business-Driven Compliance solutions for biotech and pharma can significantly advance your level of risk integration, and build processes that give you actionable business data as well as regulatory accountability. As part of our efforts, we will assess your compliance with 21CFR11, FDA 501(k), and Sarbanes-Oxley, as well as your implementation of best practices such as ISO27001 and ITIL.

Services available include:

  • Bio-Pharma Compliance Assessment
  • FDA Corrective And Preventive Action (CAPA) for Security
  • Bio-Pharma Security Management
  • Bio-Pharma Documentation & Validation