Quality And Regulatory Compliance

IntePros Consulting’s Quality and Regulatory Compliance service offering provides a unique and scalable recruiting solution for all of your FDA Compliance related needs.

IntePros Consulting’s Quality and Regulatory Compliance group works with our customers to provide specialized support to a variety of FDA regulated industries including Medical Device, Pharmaceutical, Biotechnology and Biopharmaceutical. Our support functions can be broken down into the following three focus areas:

Quality

  • Remediation
  • Warning Letter
  • Consent Decree
  • Recall Support
  • Root Cause Investigation
  • Complaint Handling
  • Corrective and Preventative Actions
  • (CAPA) and Deviation Management
  • Gap Assessment
  • Risk Management and Change Control
  • Methodology Development
  • Policy Support
  • Quality System Support
  • Training and Documentation
  • Internal and Mock Audits
  • Supplier Quality Audits

Regulatory Affairs

  • Regulatory Strategy
  • Submission Writing
  • Technical Documentation
  • 510(k) Submissions
  • Remediation and Resolution Management for Investigational Device Excemptions (IDE)
  • Adverse Event Reports (AER)
  • Premarket Approvals (PMA)
  • Investigational New Drug (IND) Applications
  • Chemistry, Manufacturing and Controls (CMC)
  • New Drug Applications (NDA)
  • Biological License Application (BLA)

Validation

  • Writing and Executing Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) Protocols
  • Facilities/Utilities Validation
  • Equipment Validation
  • Process Validation
  • Test Method Validation
  • Computer Systems Validation
  • Automated Equipment Validation
  • Software Validation
  • Process Improvement
  • Cleaning Validation
  • Risk Management
  • Lean Six Sigma
  • Controls Engineering
  • Manufacturing Engineering
  • Standard Operating Procedure (SOPs) Development
  • Validation Master Plans (VMP)

For more information, Contact IntePros Consulting Today.

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