Concept to Commercialization to Audit

As your pipeline of products move through the various stages — R&D to clinical to commercial — your regulatory needs change.

What’s more, as you progress through the lifecycle, the amount of data, technology dependencies, regulatory demands, and risk complexities expand considerably.

We ensure your technology and data adhere to regulations and that you are audit-ready, continuously. By pairing you with top Consultants who are hyper-specialists in your specific compliance needs, we ensure you have the right people within your team so you can manage change and deliver business value with quality, reliability and speed… all while maintaining continuous compliance.

How We Help

Whether we’re working with a global pharmaceutical to assure systems adhere to FDA and quality guidelines, a gene therapy startup gearing up to submit an NDA, or anything in between, we pair you with our experts who support you through the various stages of your growth.

Our specific services include:

  • IT Quality: QMS and SOP frameworks/implementation, quality and periodic reviews, change controls and industry best practices
  • Computer Systems Validation (CSV): from validation strategies through execution and traceability matrices and validation summary reports
  • Continuous Compliance: leverage AI and intelligent automation to sustain patient safety, product quality and data integrity

From helping you facilitate smoother auditing process to reducing human toil to eradicating uncertainty, we introduce quality controls and standardization so that you strengthen your culture of continuous compliance.

Analyst Report

By 2025, analysts predict that advanced technologies such as AI and robotics will have vastly accelerated the speed and efficiency of regulatory activity, streamlined processes, enhanced data capture, improved patient experience, and reduced costs.

2025 Future of Regulations Report

Areas of Expertise

We understand the different worlds of life sciences from pharmaceuticals to biotech. Our Consultants are ready from Day One to have an impact on:

  • FDA Audits
  • NDA Readiness
  • Data Integrity
  • IT Quality Services
  • Computer Systems Validation
  • SLC Development
  • Workflow Standardization
  • Product, Solution Rollouts
  • Project Management
  • Regulated Software Testing

Realize Immediate Impact

We work with some of the largest pharmaceutical companies in the world, helping them to:

Related Resources

Consultants On Demand

Scale your team fast and instantly with top technical Consultants.

Learn More

New Workplace Skills: Data Literacy

Tips for how to establish baseline data literacy within your team.

Read More

Next-Level Business Intelligence

Embrace next-level BI and a whole-of-approach to data excellence.

Learn More