Regulatory Consulting Services

Regulatory Consulting Services

Strategic and Tactical Compliance Consulting

• Regulatory Agency Issue Resolution (483’s, deficiency letters, …)
• Evaluation of Commitments (vendors, outsourcing)
• FDA Interface (Protocol review, deficiency response)
• Vendor Qualification
• GMP Expert Consultants (Consent Decrees)


Project Management

• Review contracts and provide project management for quality and regulatory needs
• Assistance and overview of data management
• Guidance and follow-up with method transfer projects
• We will communicate expectations and requirements up front with contract manufacturers or laboratories
• GMP Expert Remediation for Consent Decrees


Problem Resolution

• Conduct Investigations
• Evaluate CAPA programs
• Quality System Assessments
• Quality System Implementation
• Scale-Up
• DMF, ANDA
• Pre Approval Inspection (PAI)
• FDA 483 and Warning Letter Resolution

Validation

• Provide a compliance overview of validation and qualification protocols
• Validation Program Review
• Equipment, laboratory methods, processes, facilities, utilities and compliance with 21 CFR Part 11.

Training

• GMP Training
• New Employee Training