What We Do

Our experts provide the following services to the local and international clients to improve regulatory compliance and to reduce cost of quality.





QA Services
Auditing Services
  • Quality System Development
  • Risk Assessment & Management
  • Change Control Program
  • FDA 483 Response Support
  • CAPA Development/Support
  • Quality Policy and Manual Development
  • Vendor/Supplier Qualification
  • Validation Review
  • Equipment/HVAC Validation
  • Process Validation
  • IND/NDA/BLA Review
  • CMC Review/Development
  • cGMP, GLP, GCP Audits & Assessments
  • Contract Manufacturer Audit & Assessment
  • Quality Systems Evaluation
  • Compliance Gap Assessment
  • Mock FDA Audits & Assessment
  • Mock Pre Approval Inspection & Assessment
  • API ICH Q7 & IPEC Audits & Assessment
  • ISO 13485:2003 / 9001:2008 Audits & Preparation
  • Supplier/Vendors/Packagers Audits
Quality Control
Training
  • GMP Compliance
  • Process Development Support
  • Analytical Method Development
  • Analytical Method Transfer
  • Analytical Method Validation
  • CAPA and OOS Investigation
  • GMP & ISO Training
  • Auditors Training
  • ICH Q8, Q9, Q10 Training
  • Six Sigma White, Yellow, Green and Black Belt training
  • Laboratory training
Documentation & Process Improvements
Staffing Services
  • Write or revise GMP/ISO SOPs, Work Instructions, Quality Manuals, Standards, and Policies
  • Provide compliance radar services for USP, Ph.Eur, JP, and BP supplements, and forums to improve compendial compliance
  • Develop new and/or enhance existing CAPA program
  • R&D and Organizational Effectiveness Assessment
  • Cost-efficient (on average 2-4% less commission charged than others)
  • 1% donated to charity of your choice
  • Experienced team
  • Widely networked
  • Superior service
  • Qualified Candidates for Temporary/Full Time positions
  • Precisely understand specific organizational placement needs
  • Pre-train new hires to minimum required SOPs/Work Instructions to enable hires to start working immediately