Quality Assurance

Our expertise in global regulatory requirements combined with wide-ranging technical backgrounds and ownership philosophy enables Guosa Life Sciences to provide an end-to end package of global Quality Assurance services. Our customized services are designed to meet specific client requirements and can range from small start-ups to multinationals in scope. In addition, the services can be provided in-house, on site at multiple client locations or at third party facilities.

At Guosa Life Sciences, we are well suited to provide the global expertise, skills, and objectivity to help evaluate, improve, or build your GxP quality systems and improve your process. We currently provide Quality Assurance Services in the following categories:

a. Quality Systems Development/Management

We believe that one of the foundations of achieving performance excellence in any successful organization is a system that ensures consistency, quality and repeatability. From start-ups to multinational companies, our goal is to identify the key criteria and related procedures, processes, controls, tools and actions necessary to ensure your products are safe and effective for their intended use. Our services also include gap assessments, process improvement and SOP development.

b. Pre-Approval Inspection Preparation

Our team of global industry experts specialize in helping your organization evaluate, manage and significantly reduce your risk. With our extensive experience in R&D, Commercial and third party management, we are able to define the critical path, focus the resources, drive the process to meet every milestone and determine your organization’s ability to meet regulatory compliance and all application commitments.

c. Due Diligence Auditing

From small start-ups to multinationals, our goal is to adopt an ownership philosophy in adding value to your technical assessments for acquisition or in-licensing opportunities of technology, products and other assets in all phases. In addition, providing expert evidence to support legal actions and help you manage the risk of your investment.