Chemistry, Manufacturing, and Controls (CMC) and Quality Services

OptumInsight has a team dedicated exclusively to chemistry, manufacturing and controls (CMC) and Quality services.  These regulatory affairs specialists provide support to OptumInsight’s clients around the world.  Our consultants provide a broad range of specialized services, including:

• GMP audits and training
• Development and assessment of GMP Quality Systems
• Preparation of quality modules for CTD submissions
• Product/Batch release
• GCP consulting
• Preparation of Quality Agreements
• Preparation for Regulatory Agency Inspections
• Assist with Exit Notice/483 audit responses
• Stability protocol preparation
• Analytical validation review
• Process validation protocol and report review
• Packaging qualification protocol and report review
• Supplier/Subcontractor Qualification
• Preparation of validation master plan