5K Pharma Consulting LLC
About 5K Pharma Consulting LLC
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
Competitors of 5K Pharma Consulting LLC
Austin Company
The Austin Company is a consulting, design, engineering, and construction company offering a portfolio of services to a broad spectrum of industries nationwide. Austin offers its clients significant flexibility in the way its services are offered, delivering services under a single source... Read More
NAMSA is medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. At every stage of the product development process, we provide strategic guidance and tactical support to help clients... Read More
Products by 5K Pharma Consulting LLC
Consulting Service in PQMS: - Establishment, review, and improvement of the PQMS. - Auditing and preparation for inspections - Audit management and back-office support. - Internal audits and supplier audits. - Remediation and process improvement work. - Support in main regulatory areas of... Read more »
