Enabling Product Development
GXPQS is an independent specialty contract research organization (CRO) that provides development consulting services with a quality systems (QS) approach to companies developing biopharmaceutical products, including but not limited to drugs, biologics, and combination products. We specialize in helping these companies, starting at any stage of development, take their product candidate from research and preclinical development through clinical trials and into the marketplace using our proprietary GXP Quality System framework tailored to their specific needs.
QA and Quality Systems Development
All operations are governed by the Quality System. Oversight of the system and processes by QA are integral to the success of a company. If data and documentation are not controlled, filings may be inaccurate or delayed. GXPQS has the capability and expertise to ensure data integrity by establishing the right system(s) at the right time with the appropriate oversight and controls for the Client company’s stage of development.
Chemistry Manufacturing and Controls
One essential requirement for product approval is the ability to manufacture commercial product after completing clinical scale CMC development activities. GXPQS consultants have a proven track record of ensuring all CMC requirements are in place for production operations that meet clinical development expectations as well as approval inspection expectations.
Regulatory Affairs and Regulatory Operations
Our experts are expierenced Regulatory Affiars professionals at both strategic and operational levels. GXPQS provides guidance and support for regulatory development activities and Health Authority meetings and provide regulatory writing and submission support when needed. We also provide high quality eCTD formatted publishing and e-submission services.
Discovery and Preclinical Research
Our consultants are well-versed in early stage discovery and preclinical research and have a broad background in preclinical development. With this experience and through understanding Good Laboratory Practices (GLP) and Good Documentation Practices (GDP), we support our Clients in developing sound scientific studies, robust reports, and ensuring traceability and data integrity, ultimately to ensure that the preclinical development package supports the planned clinical trials and NDA/BLA submission.
GXPQS Expert Consultants have a broad range of experience in developing successful strategies encompassing research, development, clinical trials, and commercialization, resulting in speed to market. Through our proprietary Quality System, they can assess the complete product lifecycle and identify the strategic execution elements necessary for product approval, assist in specific areas for acute issue resolution (i.e. environmental contamination in a manufacturing suite, 483/warning letter responses and resolution, to consent decree remediation), or can provide targeted guidances for continuous improvement within the QMS.
Clinical Development Safety and Pharmacovigilance
Having robust Quality Systems and QA oversight ensures clinical trials are planned with success and efficiency in mind. GXPQS consultants provide specific clinical operations services including, but not limited to clinical project management, development of SOPs and other clinical documents, monitoring and oversight, as well as data management and SAS® programming services. Our experts are also experienced in SAE processing, narrative authoring and review, and assessment and oversight of safety & pharmacovigilance (PV) vendors, while other drug safety and PV assistance is available through GXPQS strategic partnerships.