Life Sciences

Ready for the highly regulated healthcare industry

The fast-changing, yet highly regulated healthcare industry is an excellent match for SQA’s agility and technical depth. Our long and successful association with the healthcare industry is the result of our responsiveness, subject matter expertise, and best practices from all industries that we serve. SQA supports our clients in the Life Sciences through audits, assessments, CAPA management, desktop evaluations, inspections, and remediation.

SQA offers a cost-effective, low-carbon footprint solution, engaging a worldwide, multidisciplinary team of experts to provide quality support services to the pharmaceutical, biologics, and medical device industries. SQA associates are qualified internally and locally placed, providing expertise in global and location-specific regulations and auditing capabilities in many languages.

SQA and associates have experience providing supplier qualification and monitoring activities, including:

Pharmaceuticals

SQA is proud to integrate its services with the world’s largest pharmaceutical companies and their quality supplier teams. Our teamwork provides a global footprint and subject matter expertise that supports our client’s strategic priorities and their patient’s safety.

Biologics

SQA studies the differences between biologics targeting disease pathways at a molecular level, and how gene therapies modify genetic material to address disease at its source. Our SQA experts are pioneers within Biologics, providing our client partners confidence that their drugs maintain high purity and stability and are produced consistently, which is essential for patient safety.

Medical Device

SQA’s extensive assessment tool provides medical device manufacturers and their supply chain development solutions that allow for all components and finished products to meet rigorous regulatory standards, maintain high levels of safety and reliability, and reduce the risk of defects, thereby protecting patient safety and supporting compliance with industry regulations.

Gene and Cell Therapy

Large molecule therapies are essential to patients to treat complex diseases at a cellular and molecular level. SQA’s senior qualified auditors and engineers help our clients adhere to strict regulatory standards, maintain high purity and potency, and manufacture therapies under precise conditions, which is critical for patient safety and treatment efficacy

BY THE NUMBERS

3000+ audits annually across 90+ countries around the world