Regulatory
LSW has partnered with an outstanding group of regulatory firms with expertise in helping Life Science with CRO/CLO/CMO, Device management, and QA/QC Consulting
Developing regulatory and clinical strategies, implementation of those strategies; overseeing all aspects of clinical studies (selecting and qualifying investigators; monitoring, data management, Statistical analysis and evaluation, medical writing for reports and papers); managing marketing applications writing, preparation and submission; writing and/or reviewing clinical SOPs; managing the QA function (gap analyses, audits, GMPs/QSR)
At ATS, we understand that there are unique considerations in the design and manufacture of medical devices. Our world class manufacturing and test capabilities coupled with our robust processes help ensure product traceability and reliability for our medical device customers. We have significant experience in building non-invasive, Class I and II medical instrumentation, particularly medical diagnostics and imaging
Jubilant HollisterStier provides a full-range of support and services to streamline the manufacturing process. We offer on-site assistance from process qualifications and regulatory submittals through product release. Our Quality Unit maintains an integrated quality assurance program that emphasizes quality design, validation and proper use of facilities and equipment. Quality is part of Jubilant HollisterStier’s corporate culture and is held to a high standard throughout our facilities.
Axio provides biostatistics support services to facilitate and expedite clinical trial results. We are focused on delivering timely, best-in-class data and analysis to help biotechnology and pharmaceutical companies optimize productivity and mitigate risk in the clinical trials process.