Services

We offer comprehensive consultancy services tailored to the 

unique needs of the pharmaceutical and life sciences industries.

Quality Auditing

  • US FDA and EU GMP Inspection Readiness
  • Warning Letter Remediation
  • Supplier Qualification Audits
  • Self-inspection effectiveness
  • Data Integrity Audits
  • Computer system Audits
  • For Cause Audits

Validation Support

  • Facility Validation
  • Equipment Validation
  • Process Validation
  • Analytical Validation
  • Computer System Validation

Training and Certification

  • Auditor Training
  • Data integrity Training
  • GxP Trainings – Online & Classroom

Regulatory Affairs

  • Drug Master File
  • Dossiers for Finished Dosages
  • Deficiency letter resolution

Manufacturing Excellence

  • Process improvement
  • Operational improvement
  • Cost optimization
  • Equipment Automation
  • Solvent recovery and recycle

Sourcing

  • Sourcing of intermediates
  • Sourcing of APIs
  • Sourcing of impurity standards
  • Custom Synthesis Support
  • Contract Research Support
  • Contract Manufacturing Support

Projects

  • New Facility - Project support
  • Facility expansion and modification support