Life Science Outsourcing

Quality Assurance

From ISO and ISTA standards to FDA regulations, our quality assurance services ensure all requirements are being met.

Quality Assurance
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
ISO 17025
Accredited Packaging Lab
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FULFILLMENT & DISTRIBUTION


Quality Assurance

Life Science Outsourcing’s quality assurance solutions that begin with the right people and the proper understanding of what quality means to the customer and where the product is used.

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Quality Assurance Expertise

We train our staff to believe in two simple credos – “Our client’s customers are our customers” and “The customer determines customer satisfaction.”

We ensure all standards and processes are observed, then go one step further with a more subjective question — Is the order is packaged and processed well enough to be used on a family member or friend once it arrives?

Our Enterprise Resource Planning (ERP) system controls all order processing and inventory control. Unlike many fulfillment houses still utilizing paper systems with no verification, Life Science Outsourcing’s Fulfillment and Distribution services inspect the shipment for sales order accuracy, product accuracy, lot tracking accuracy, and overall packaging.

To verify all inbound shipments, we ask our clients to provide a simple file for all inbound Purchase Orders. Once received, the goods will go through the Fulfillment & Distribution receiving inspection department before going into inventory

FDS complies to Internal and External customer requirements including a secured GMP warehousing facility, Lot traceability and FIFO.

Certifications and Certificates

  • ISO-13485
  • FDA registered
  • ISO-9001
  • ISTA International Safe Transportation Association
  • ASTM International
  • 21 CFR compliant

FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

Ready to get started?

Talk to a specialist about quality assurance.

Quality Assurance | LSO