PharmaQual

Services

PharmaQual is total solution provider in the field of pharmaceutical industry, providing hands on expertise in the following - but not limited to - areas:

• Designing & Establishment of Quality Management System (QMS) for API & FDF
• Risk based GAP analysis in existing QMS & its mitigation
• QbD at R & D ( API & FDF ) including Tech Transfer to commercial production
• Due diligence audits for CRO/CMO & Compliance audits
• Vendor selection/evaluation/audits
• QbR & Strengthening of Internal audit process
• Support to response 483’s / Warning letter etc
• Management reviews & setting of Quality KPI’s
• Cost reductions proposals based on trends
• IT enable Quality Management Systems ( Trackwise/LIMS/e-BMRs etc)
• Qualification / Validation & Documentations
• Regulatory Consulting and dossiers Submissions.
• Projects & Automation
• Facilities & Supplies
• Setting up of Manufacturing lines & process optimization
• Quality Control, Testing & Documentation
• Training & Capability Building

PharmaQual is not just your consultant but a partner in your successful journey