We can guide efforts in handling 483s, warning letters, consent decrees, risk management and proactive quality strategies. We provide quality, regulatory, and compliance guidance within both Medical Device and Pharmaceutical Industries:

Medical Device Services

Quality Engineering and Quality Assurance

  • Corrective Actions and Preventative Actions
  • Root Cause Investigation
  • Complaint Handling
  • Risk Management
  • Design Controls
  • Production and Process Control
  • Change Control
  • Audits and GAP Assessments
  • Warning Letter and Consent Decree Remediation

Manufacturing and Product Development

  • Product Life Cycle Management
  • Requirements Development
  • Process Validation
  • Test Method Validation
  • Equipment Validation
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualifications (PQ) Protocols

Regulatory and Compliance

  • Investigational Device Exemptions (IDE)
  • Pre Market Approvals
  • Adverse Advents Reporting
  • 510k submissions
  • Risk Management

Pharmaceutical Services

  • Active Pharmaceutical Ingredients (APIs)
  • Validation
  • Quality By Design (QBD)
  • Serialization/Unique Device Identification (UDI)
  • Cleanliness standards
  • Labeling of ingredients to ensure consistency
  • Lab compliance services
  • Compliance with foreign markets