Quality Assurance and Compliance Services
Quality Assurance (QA) lies at the foundation of good clinical research. At Aptiv Solutions, we pride ourselves on our excellent reputation in the field of QA as applied to our own clinical development services or to our comprehensive QA service offering to pharmaceutical and biotech companies.
Objectivity is critical to fulfill the complex role of quality assurance professionals. To ensure we conduct unbiased assessments, our organization separates the roles of QA from the operational reporting structure. Our auditors offer this same impartiality for your studies and can enhance your compliance efforts.
Our QA team consists of thirteen senior auditors with expertise in GCP, GPVP, GLP, GMP, ISO 9001 and ISO13485 and they have an average of fourteen years industry experience. We are a leader in helping Medical Device start-up companies establish quality systems that will enable them to obtain Notified Body registration.
Auditors are located throughout the United States, United Kingdom, France, Switzerland and Germany, and have conducted audits of clinical trials in forty-five countries including the regions of the Americas, and Eastern and Western Europe. Our staff can conduct business in multiple languages.