5K Pharma Consulting LLC

Consulting services to pharmaceutical industry with focus on compliance and strategic process optimization in QA, QC, and Production. Services include:
Pharmaceutical Quality Management System
- Establishment, review, and improvement of the PQMS.
- Auditing and preparation for inspections.
- Remediation and process improvement work.
- Applied experience in areas of US-FDA, EU-EMA, South Am.-ANVISA.
- General Quality Assurance and documentation.
Quality Control
- Method transfer, Optimization, QbD and PAT.
- Laboratory management and data integrity.
- Analytical work and release within operations.
Production - Manufacturing and Packaging
- Production process optimization and launch readiness.
- Production systems, problem solving, and efficiency increases.
- Product development and transfer from R&D to production.
Project Management
- PMO and project oversight, operational excellence
- Product transfer and launches