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Our Services
Quality Systems Development and Quality Assurance
The Quality System (QS) is the infrastructure that defines a company’s ability to provide consistent, compliant, and high-quality deliverables by documenting processes, procedures, and responsibilities for achieving quality objectives. All operations are governed by the QS and oversight of the system and processes by QA is integral to whether a company is successful. GXPQS has the expertise to assist companies in establishing a phase-appropriate QS and ensure appropriate oversight of those systems.
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 experienced Regulatory Affairs 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 Operations
Our consultants are well-versed in early stage discovery and preclinical research and have a broad background in preclinical development. With this experience and thorough 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.
Strategic Consulting
GXPQS Expert Consultants have a broad range of experience in developing successful strategies encompassing research, development, clinical trial conduct, 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 guidance for continuous improvement within the QMS.
Clinical 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. Our experts are also experienced in SAE processing, narrative authoring and review, and assessment and oversight of safety & pharmacovigilance (PV) vendors.
