At Epista, we offer consulting services across areas of Life Science. From regulatory to clinical to production and everything in between, we have been dedicated to Life Science since our founding in 2009. Our subject-matter-experts work at the intersection of compliance and business to help you continuously improve to achieve more. Our consulting services cover the areas of Quality and QMS, Compliance, Security, Project Management, Remote Audits, and more. Learn more below:
Within quality and quality management, Epista consultants can fill a variety of gaps in your business including:
As experts at the intersection of compliance and business, our team has a wide array of knowledge across compliance areas including:
EU/US GMP, GDP, & Medical Devices
Gap analysis, establishment, reconstruction, extension of QMS systems
Security is an important building block for Life Science companies. That is why our experts have deep understanding of security requirements for the Life Science industry. Our expertise covers:
Records & Information Mangement (RIM)
Regardless of the IT system or area of expertise, Epista's consultants have the knowledge to lead your proejcts from system introduction and implementation through Product Life Cycle Management (PLM).
IT System Introduction & Implementation
Product Life Cycle Management
Why remote audits? According to current regulations, supplier arudits are needed as a part of the supplier qualification. Sometimes, these audits cannot be performed on-site. We solve this with remote, paper-based audits (distant assessment) where certain parts of the audit are performed via a web meeting.
We have developed a "best practice" on how a remote audit can be done.
If an on-site audit is considered necessary, it will be done in areas that could not be inspected during the remote audit. This means that this will be a shorter audit focusing on the areas that need further review according to the risk analysis.
We also offer consulting services across the IT system life cycle. Learn more about those services here.
If your business could benefit from any of above services, or even something else, please get in contact and we will help you find the solution that is best for you.