Technical Expertise for Manufacturers of Pharmaceuticals and Biologics

Technical Expertise for Manufacturers
of Pharmaceuticals and Biologics

Inspection Readiness

Being ready for the inevitable is key to business continuity and success. Proactive organizations look to stay ahead of the potential threats to the business like random regulatory inspections. That means having a formal process in place with trained Subject Matter Experts on-the-ready.

The typical related services we provide for Inspection Readiness are the following:

Business people planning strategy

Planning/Strategy

  • Setting up first impressions
  • Selection of SME’s
    • Competency
    • Performance under stress
    • Demeanor/attitude
    • Adaptability
  • Training
    • Do’s and Don’ts
    • Role Playing/simulations
    • Interrogation techniques
    • Case Studies
Business meeting

Backroom Design/Support

  • Leader/Coordinator
  • Document control process, timeliness of delivery
  • Verification of requests
  • Pre-review of documents
  • Understanding intent and direction of requests
Compliance graphic

Regulatory Responses

  • Response Leader, Team
  • Establishing a process
  • Timeliness
  • Concurrent remedial activities
  • Anticipating reaction/action
Compliance rules

Regulatory Monitoring

  • Selecting a Leader
  • Impact assessment on corporate environment
  • Sources of information, data and trends
  • Process for communications to leadership
  • Best Practices, Industry Trends
  • Relationship with regulatory agencies
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