Consulting Services

Examples of Consulting Services Offered by CPT:

Remediation of FDA Compliance Issues

• 483 Observations and Warning Letters
• Formulation of Corrective Action Plans
• Generation of Response Letters

Auditing Services

• GMP Compliance Audits (CMOs, Suppliers, Testing Labs, and Warehouse/Logistics)
• FDA Inspection Preparedness Audit
• Quality Audits (Cosmetic/Personal Care facilities)
• Third-Party Internal Audits

Quality Management System (QMS) Improvement

• Assessment of Current QMS with GAP Analysis
• Cost-Effective Improvement Strategies
• Creation of Site-Specific Standard Operating Procedures (SOPs)
• Quality Testing Programs (including Skip-Lot Testing)

MoCRA (Modernization of Cosmetics Regulation Act) Preparedness

• Delineation of MoCRA Requirements
• Adverse Events Program
• Creation of Product Safety Dossiers
• Compliance Strategies

Training (‘On-Site’ or ‘Virtual’)

• GMP, GLP, GCP and MoCRA
• Focused Topics (e.g., OOS, Change Control, Investigations, Adverse Events, and Stability)

Supply Chain Quality Management

• Vendor Qualification
• Validation of Vendor Certificates of Analysis
• Quality Agreements
• Quality Monitoring (including Skip-Lot Testing Programs)

Validation Design and Testing

• Process
• Cleaning
• Analytical Methods
• Equipment

OTC Drug Launch Planning

• Specifications
• Validation
• Stability

Review of Product Claims: US Market

• Cosmetic
• Dietary Supplement/Nutraceutical
• OTC Drug

Forensic Investigations – Chemistry or Microbiology

• Batch Failures
• Water System Failures
• Negative Trending

Other Consulting Services – upon request.