From Concept to Commercialization to Audit

As your organization moves through the various stages of product maturity — from R&D to clinical to commercial — your need for quality practices changes. What’s more, as you progress through the lifecycle, the amount of risk when it comes to patients, products, regulatory considerations and your overall business expands 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 to so you can manage change and deliver business value with quality, reliability and speed… all while maintaining continuous compliance.

Services Overview

Whether we’re working with a global pharmaceutical firm to assure their systems meet FDA, Global, and their internal standards, an exciting gene therapy startup gearing up to submit their NDA, or anything in between, we pair you with our pharmaceutical experts who can support your through your various stages of growth.

Our specific services include:

  • CSV/CSA: regulatory, risk and impact assessments; validation strategies to align with regulatory requirements, corporate methodologies and business needs as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4; project management; cloud-based OTS system implementation (ensuring implementation risks are understood, system meets GxP requirements, ensure vendor validation packages meet standards)
  • Quality and Compliance: periodic review process; data integrity programs; independent quality reviews/approvals; IT QMS evaluations; IT compliance

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

Impact and Outcomes

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

From Our Community

"Thank you for all that your organization did to support the badly needed changes in testing, agile and process improvements. You and your team did make a difference."

Dan Sheehan, Business and IT Executive

Hyper-Specialization

We understand the different worlds of pharma. We know the language, the differences, and the needs. Our Consultants are ready from Day One to have an impact on:

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