127/Broadway Business Hub, Opp. to Bharat Petroleum Bhayali, Vadodara-391 410, Gujarat. India.
 

Compliance

Shriharipharmachem further supports Quality through the efforts of supporting Regulatory Compliance, reviewing quality systems, outcomes and regulatory responses. Additionally, services are provided to directly support the Regulatory Process across the broader scope and aiding in responses and submissions.

  • AFMEA
  • Processes
  • Programs
  • Training
  • Remediation
  • Risk Analysis
  • Quality Systems
  • Data integrity
  • Investigations
  • Technical Reports
  • Auditing & Gap Assessment
  • Personnel, Knowledge & Skills
  • Policies, Procedures, SOPs
  • Reports (e.g., APR, DHF, DMF)
  • Protocol, Reports
  • Inspection Readiness
  • Systems Review, Training, Mock Interviews, Coaching
  • Regulatory Documents (e.g., FDA, HC-SC, EMA, ISO)