Quality Management System

Quality Management System

Quality is an integral part of everything we do at Stelis. We reliably develop and manufacture products that meet our clients’ expectations and adhere to the highest worldwide regulatory standards. 

Our experienced quality and regulatory personnel help us meet the highest global quality standards, ensure compliance and guide our clients through the regulatory approval. Our large-scale commercial use facilities were designed with consultation from international regulatory agencies, including the USFDA, and a holistic and systematic approach to building and sustaining the Stelis Quality Culture.

A comprehensive architecture starting from developing and deploying robust quality systems, continuous governance through effective metrics, risk mitigation strategies, and continuous improvements help us build a proactive, responsive and sustainable quality culture in the organization that ensures all-time compliance with global standards.

Our Quality policy is “to develop and deliver products of high and consistent quality that will meet the expectations of our customers while adhering to the highest standards of worldwide statutory and regulatory bodies.” We achieve this by design and effective deployment of a robust quality management system.

Our quality systems are IT-enabled through SAP Enterprise Resource Planning & Material Management, TrackWise QMS management, BIOVIA Document Management, Training Management, and Laboratory Information Systems for effective governance and systems.

cGMP Quality Control is an integral part of all our manufacturing processes. Our Quality Control and Analytical Development teams work collaboratively to transfer analytical methods from process development to cGMP manufacturing. We have complete onsite Quality Control laboratories in all our facilities. We carry out all key activities, including raw material, environmental, microbiology, stability management, in-process control, drug substance, and drug product testing. Our instrumentation and wet laboratories are equipped with HPLCs, UPLCs, GCs, UV Spectrometers, ICP-MS, KF Titrator, FTIP, AAS, Liquid particle counter, Torque, Force Testing Machine, Polarimeter, Refractor, TOC Analyzer, among several others. Our molecular biology possesses capabilities to run Bioassay, ELISA, and RT-PCR tests and has Liquid Handling Systems. We conduct various microbiological tests, including sterilization, environmental monitoring, endotoxin testing, sterility (in isolators), microbial identification, and microbial control. Our microbiology laboratory is qualified and well- designed, with a dedicated culture handling area, BET testing room, and Bioburden testing areas for holistic contamination control in our manufacturing facilities.

Stelis Quality Mission

To reliably develop and manufacture products that meet our partner’s expectations and adhere to the highest worldwide regulatory standards. At Stelis, we achieve this by design and through our quality framework.

Quality by Design

Our Quality by Design enables us to meet global regulatory standards




















Risk Mitigation


Quality Culture


Continuous Surveillance


Rapid Response


Any Time Compliance

Regulatory Audits / Approvals

Seamless regulatory filings and approval for rapid commercialization

Q4, CY-21

*Q1, CY-22

*Q1, CY-22

Q1/Q2, CY-22

*Q1, CY-22

Q4, CY-21

*Q1, CY-22

*Q1, CY-22

Q1/Q2, CY-22

* Expecting audits and regulatory approvals during CY-22 for client filings.