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GMP Services

Experience

Experience, competence and dedication. We offer a staff of talented individuals to fill your validation, compliance, and technical services needs. We will provide you with talent that fits your specific requirements. Our flexible team will work under your supervision assuring that your goals are successfully 

Audit Services

We perform audits to suppliers of pharmaceutical industry according to:

  • CFR 21 part 210/211
  • CFR 21 part 110/111
  • EU GMP Eudralex Vol. 4
  • ICH Q7
  • ISO 13485
  • ISO 9001:2015

 

Quality systems & GMP Compliance

  • Customer Complaint management system
  • CAPA Management
  • Product Quality monitoring system
  • Change Management system
  • CFR 21 part 11 Compliance
  • Compliance Assessment and Gap Analysis
  • Audit Services

Validation

  • Validation Master Plan
  • Validation Protocols/ Reports/ Fields execution
  • Computerized System Validation and
  • Cleaning Validation
  • Equipment Qualification
  • Facility Qualification
  • Process Validation