Beyond Due Diligence

We appreciate the need for speed but know when to look for the speed bumps. Every organization manages its regulation and compliance portfolio differently. Our staff is trained to ask the right questions when working with a 21CFR.11 complaint system or navigating IT user access controls for Sarbanes Oxley. Further to that, we will take the tedious workloads that are required to satisfy your control needs.

 

      Establishing technical controls to match SoX requirements

      Supporting documentation for system-validation efforts

      Assisting with laboratory system expansion projects

      Leveraging automation for QA based workloads 

      Assisting with CSV activities for GxP compliant systems

 

From clearing a series funding, preparing for an IND, or entering a clinic, our proven processes will give you the assurance you need to move in scale.