A Compliant QMS Means Success
The FDA requires biotechnology companies to follow Current Good Practice requirements and incorporate them into your Quality Management System (QMS).
Achieving an auditable standard of quality is a significant challenge for life science businesses. We focus on enabling our clients to achieve the required levels of product quality in a way that delivers both operational excellence and an accelerated achievement of your goals.
We offer a wide range of QMS Consulting Services for Biotechnology Companies, including:
- Quality System Audits
- Quality Assurance (QA) and Regulatory Affairs (RA) Outsourcing
- QA and RA Due Diligence Audits of Critical Vendors
- FDA QSR Consulting
- FDA GxP Audits
- FDA GxP Consultants for Quality System Implementation
We also know firsthand that the most difficult aspect of compliance is maintaining it. Every year. Every month. Every week, there are actions that must be taken to demonstrate you’re in compliance with your Quality System. MethodSense can be part of your virtual quality team to ensure your auditability. Learn more about our On-Call Quality Support services to see if they are right for you!