Responding to regulatory issues is not only good business practice, but many times it’s mandatory. Our staff includes former FDA investigators who can help your firm.
USDM Life Sciences' highly qualified team of auditors employs FDA’s Quality Systems Inspection Technique auditing approach to ensure that your regulatory commitments are met and you can demonstrate your Quality System is operating in a state of control.
USDM’s auditors have successfully conducted 100s of audits in the US and globally for some of the most notable Life Sciences companies such as yourself.
USDM audits cover the entire drug development lifecycle: including all GxP Compliance, Manufacturing Audits, FDA Supplier Audits, CMOs, APIs, Sterile Injectables, Auditing SaaS Hosting Vendors, Cloud Compliance, Medical Device Audits, PAI Audits, Risk Management-Audits, Mock Audits, and FDA compliance audits.
Some of our notable areas of expertise are pre-FDA readiness, vendor pre-qualification, Facility Management Compliance, FDA Validation, GxP Compliance, Personnel Qualification and Training, Post-Market Compliance, Quality Management Systems and IT Compliance.
USDM has a flexible delivery model to accommodate the ever-changing workload requirements. USDM’s auditing practice’s flexible delivery approach can meet any of your needs:
Project Based: we agree on specific tasks, timelines and deliverables. This is per audit or per audit groups.
Staffing: you can pull in one of our auditors to assign to some of your extra workload. We can help with the many logistics involved with audit preparation and planning.
On-Demand: blended onsite/onshore/offshore model for managed services and validation.
USDM’s flexible delivery auditing approach can meet your needs.
If you have any questions, we offer a hotline to get questions answered by ex-FDA auditors.
Contact us now at 888-231-0816.
Or, you can email us your questions.