QBD SCIENTIFIC Consulting Dietary Supplement and Pharmaceutical Quality Consulting Services

• FDA Form 483/Deficiency Letters and Warning Letter Review, Response and Support
  
• Master Manufacturing Record Review (Batch Records), Design and Support
  
• Raw Material/Product Specification Review and Assistance
• Raw Material Supplier Audits
• Vendor Qualification Audits
• Contract Manufacturing and Contract Laboratory Compliance Audits
• GAP Analysis Audits for Quality, Laboratory, and Manufacturing Operations
• On-site Training for Laboratory and Quality Personnel
• Quality System Design (SOP, CAPA, OOS)
• Standard Operating Procedure, Work Instructions and Quality Manual Writing
• Stability Program Design
• Evaluation, Trending and Assessment of Stability Data (Setting Specifications)
• Data Integrity Review and Verification.
• Waters Empower Software Expertise
• Writing and Reviewing Analytical Method Verification/Validation/Transfer Protocols and Reports (USP, EP, Non Compendial)
• Analytical Method Development Design and Support
• Writing, Reviewing, and Assessing Analytical Test Methods, Specifications, and Procedures
• Technical Review and Investigation of Analytical Test Data
• Analytical Testing Laboratory Construction and Design Support
  
• Dietary Supplement Labeling Compliance Review
• Temporary On-site Quality Unit Support for Customer Audits and Responses
• Writing and Reviewing Chemistry Manufacturing and Controls (CMC) Modules 2 and 3 (Canada, USA, Australia)
• Critical Quality Assurance Review and Assessment of Laboratory and Manufacturing Processes

QBD Scientific Consulting Co., Inc.

Dietary Supplement and Pharmaceutical Quality ConsultantS