Quality Assurance

Quality Commitment

Nanosyn is committed to delivering quality products and services across all the facilities both at the early stages of development and at the stages of manufacturing for clinical trials and commercial production. The quality and integrity of the science and technical processes is paramount.

Quality System

Our Quality system is designed for clinical trial & commercial APIs and based on cGMPs (defined by ICH Q7 and 21 CFR 210 & 211).

The Quality Unit is led by our experienced Director of Quality Assurance with over 15 years in FDA regulated businesses and 9 years in her current position, responsible over the QA, QC and analytical development areas.

Quality Control

The Quality Control unit routinely performs GMP final release QC testing, analytical method validations, and stability studies as requested by our clients and in accordance with applicable and cGMP regulations and ICH guidelines.

A dedicated team of analytical chemists ensures that raw materials, intermediates, and APIs conform to the specifications via qualified or validated (stage appropriate) methods.

Our Analytical laboratories incorporate a broad range of qualified analytical instruments.

Highlights

The facility has been FDA registered since 1979 and was last inspected by the FDA in July 2018; no 483 observations
Site produces cGMP materials for clinical trial & commercial use
Quality system based on cGMPs (defined by ICHQ7 and 21 CFR 210 & 211)
Our facilities are regularly audited by clients, as we host dozens of customer audits each year
Analytical laboratories incorporating a broad range of qualified analytical instruments