GxP Central
GxP Central, headquartered in Las Vegas, Nevada, is dedicated to accelerating life science product development and commercialization for biopharmaceutical, medical device, and diagnostic companies by providing clinical, regulatory, and quality compliance solutions. The company emphasizes quality, compliance, transparency, confidentiality, and ethical practices, with a team of experienced consultants offering services across various industries and regions.
Industries
Nr. of Employees
small (1-50)
GxP Central
Las Vegas, Nevada, United States, North America
Products
GMP Audits
Audits of sites, suppliers, and supporting laboratories including mock audits and gap analyses.
GCP Audits
Specialized GCP auditing focusing on Phase I-III facilities, safety reporting databases, and clinical trial documents.
BioSpring Audit Report
Audit report for BioSpring from Germany, available for purchase to reduce audit costs and ensure GxP compliance.
SOP writing
In-depth and specific quality procedures to help organizations remain compliant while avoiding unnecessary expense and ensuring proper training.
GLP Audits
Laboratory evaluation, facility inspection, and record reviews for GLP compliance.
SOPs Writing
Standard operating procedure writing and documentation across clinical, manufacturing, non-clinical, and electronic record domains.
GMP Audits
Audits of sites, suppliers, and supporting laboratories including mock audits and gap analyses.
GCP Audits
Specialized GCP auditing focusing on Phase I-III facilities, safety reporting databases, and clinical trial documents.
BioSpring Audit Report
Audit report for BioSpring from Germany, available for purchase to reduce audit costs and ensure GxP compliance.
SOP writing
In-depth and specific quality procedures to help organizations remain compliant while avoiding unnecessary expense and ensuring proper training.
GLP Audits
Laboratory evaluation, facility inspection, and record reviews for GLP compliance.
SOPs Writing
Standard operating procedure writing and documentation across clinical, manufacturing, non-clinical, and electronic record domains.
Services
Execution of GCP, GMP, GLP and pharmacovigilance audits, mock inspections, and corrective action plans for facilities, vendors and clinical sites.
Design, implementation and remediation of QMS, including SOP suites, electronic/paper workflows and certification readiness.
Creation and review of SOPs, forms, templates and related quality documentation to ensure operational compliance and clarity.
Validation planning and execution for processes, equipment and computerized systems with attention to electronic records and signatures controls.
CRA monitoring, monitoring visit execution, study coordination and on-site support during inspections across multiple therapeutic areas and trial phases.
Assistance with IND/NDA/ANDA/DMF preparation, dossier coordination, and post-approval change submissions.
Execution of GCP, GMP, GLP and pharmacovigilance audits, mock inspections, and corrective action plans for facilities, vendors and clinical sites.
Design, implementation and remediation of QMS, including SOP suites, electronic/paper workflows and certification readiness.
Creation and review of SOPs, forms, templates and related quality documentation to ensure operational compliance and clarity.
Validation planning and execution for processes, equipment and computerized systems with attention to electronic records and signatures controls.
CRA monitoring, monitoring visit execution, study coordination and on-site support during inspections across multiple therapeutic areas and trial phases.
Assistance with IND/NDA/ANDA/DMF preparation, dossier coordination, and post-approval change submissions.
Expertise Areas
- Regulatory compliance and GxP audits
- Quality Management Systems (QMS) development
- Clinical trial management and monitoring
- Technology transfer and manufacturing scale-up
Key Technologies
- Electronic data capture (EDC)
- Cloud / hybrid QMS platforms
- Statistical design of experiments (DOE)
- Technology transfer methodologies