Services
Quality Management Systems Support/Auditing (GxP)
Quality Management Systems Support/Auditing (GxP)
Quality Management Systems Support/Auditing (GxP)
- Establish, plan, and manage Master Audit Plan/Schedule and follow to closure for GxP activities (i.e., CAPA Effectiveness Checks)
- Change Control Management – support globalization of procedures
- Personnel Training Plans - for global GxP staff
- Standard Operating Procedures (SOPs), Company Policies, Work Instructions, and supplemental forms (i
- Establish, plan, and manage Master Audit Plan/Schedule and follow to closure for GxP activities (i.e., CAPA Effectiveness Checks)
- Change Control Management – support globalization of procedures
- Personnel Training Plans - for global GxP staff
- Standard Operating Procedures (SOPs), Company Policies, Work Instructions, and supplemental forms (ie, Templates/Forms)
- Inspection readiness (documents up to date, staff preparation/training efforts for agency inspections)
Auditing
- Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)
- Ensure Quality of Reports for Validated Systems (software), Equipment, and Instrumentation to support GxP 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.
- Batch Record Review
- Label Review (for consolidation of labels used for distribution purposes)
Medical Writing Support
- Draft Safety Patient Narratives using Council for International Organizations of Medical Sciences (CIOMS [Clinical Study Pharmacovigilance Notes])
- Pre-Clinical or Quality section(s) of regulatory filing(s) in collaboration with Subject Matter Experts (SMEs)
- Formatting and editing services for all of the 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
- CRO vetting for new study(ies)
- Vendor Oversight
Training Courses
- Inspection Readiness
- Good Clinical Practices (GCP)
- Good Documentation Practices (GDP)
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
- Good Pharmacovigilance Practices (GVP)
- GxPs Overview
- (Includes GCP, GDP, GLP, GMP, GVP)