Quality Operations

Your partner for maximum compliance

Committed to helping life science companies deliver compliant products that meet industry’s regulatory requirements. 

Quality Assurance Services

  • Drive continuous improvement of core processes 
  • Development of quality management system
  • Maintain QA documentation
  • Write SOPs for manufacturing and laboratory processes 
  • Root cause analysis 
  • Risk assessments 
  • Technical writing
  • Deviation management 
  • Audits and inspection preparation for regulatory compliance
  • Review of cGMP documents
  • Coaching and training 

Quality Control Services

  • Analytical method development 
  • Method transfers 
  • Clean room monitoring
  • Analytical investigations for events, complaints and product recalls 
  • Batch failure investigations 
  • Sampling, inspection and testing  
  • Ensure functioning of analytical instruments and equipments 
  • Back up and retrieval of electronic data 
  • Establish guidelines on cGMP and GLP 

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