Enabling Product Development
A New Approach
GXPQS is an independent specialty contract research organization (CRO) that provides development consulting services with a quality systems (QS) approach to companies developing virtually all types of pharmaceutical, medical device and combination products. We specialize in helping these companies, starting at any stage of product development, take their product candidate from research and development through clinical trials and into the marketplace using our proprietary GXP Quality System tailored to each Client’s specific needs.
QA and Quality Systems Development
GXPQS has the capability and expertise to ensure data integrity and documentation are secure and controlled.
Chemistry, Manufacturing, and Controls
GXPQS consultants have a proven track record that ensures all CMC requirements are in place for production and testing operations that meet approval inspection expectations.
Regulatory Affairs and Electronic Publishing
Our experts have experience in all areas of Regulatory Affairs at both the strategic and operational levels. GXPQS can confidently provide guidance and support when it is needed.
Discovery and Preclinical Research
Our consultants are well-versed in GLP/GDP and advise clients on developing sound scientific studies and robust reports for traceability.
GXPQS evaluates and identifies strategic execution elements nesecsary for product life cycle and identification of strategic and execution elements necessary for product approval.
Clinical Development Safety and Pharmacovigilance
We provide specific clinical operations and medical affairs services. We achieve this by sending qualified physicians that offer medical management and oversight.
We also can supply training materials such as agendas, detailed course notes, and supporting reference material which, when completed, certifies them in GXPQS.
Medical Writing, Data Management, and Biostatistics
With over 10 years’ experience our consultants can help you write reports for preclinical research and chemistry. This includes comprehensive medical and technical writing services in all operational areas.