Services
Quality Management Systems Support/Auditing (GxP)
Quality Management Systems Support/Auditing (GxP)
Quality Management Systems Support/Auditing (GxP)
- Manage Auditing Schedule and status for all GxP activities (ie, plan and coordinate audits)
- Change Control Management – support globalization of procedures
- Create (Global) Personnel Training Plans
- Author/Draft Standard Operating Procedures (SOPs), Company Policies, Work Instructions, and supplemental forms (ie, Templates/Forms)
- Ensure inspect
- Manage Auditing Schedule and status for all GxP activities (ie, plan and coordinate audits)
- Change Control Management – support globalization of procedures
- Create (Global) Personnel Training Plans
- Author/Draft Standard Operating Procedures (SOPs), Company Policies, Work Instructions, and supplemental forms (ie, Templates/Forms)
- Ensure inspection readiness (documents up to date, preparation efforts for audits/inspections)
Auditing
- Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and non-GLP (CRO pre-qualification audit)
- Ensure Quality of Reports for Validated Systems (software) and Validated Instrumentation to support laboratory Procedures
Document Quality Control (QC)/ Medical Writing
Quality Management Systems Support/Auditing (GxP)
Quality Management Systems Support/Auditing (GxP)
- Quality Review of supporting Documentation intended to be submitted to regulatory agencies for drug approval including: Investigational New Drug, Protocols, Informed Consent Forms, Clinical Study Reports, Biologics License Application, New Drug Application, Investigational Brochure, Briefing Book, Regulatory Responses, and Product Labelin
- Quality Review of supporting Documentation intended to be submitted to regulatory agencies for drug approval including: Investigational New Drug, Protocols, Informed Consent Forms, Clinical Study Reports, Biologics License Application, New Drug Application, Investigational Brochure, Briefing Book, Regulatory Responses, and Product Labeling.
Medical Writing Support
- Draft Safety Patient Narratives using Council for International Organizations of Medical Sciences (CIOMS [Clinical Study Pharmacovigilance Notes])
- Formatting and editing support/ document QC as described above
Clinical Operations and Training Courses
Quality Management Systems Support/Auditing (GxP)
Clinical Operations and Training Courses
- Implementation of GCP SOPs
- Risk Management and Strategy
- Process Improvement
- Quality Agreements and Plans
- Issue Management and Vendor Oversight
Training Courses
- Good Clinical Practices (GCP)
- Good Documentation Practices (GDP)
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
- GxPs Overview
- (Includes GCP, GDP, GLP, and GMP)