We are here to provide QA solutions!
About us
Qualix, a team of qualified professionals with extensive knowledge in auditing, compliance, and quality management systems in the pharmaceutical/ Cosmetic/ Food industry. We are here to help our clients achieve their goals through innovative and cost-effective solutions
Who We Are
At Qualix, we are more than a consultancy; we are a team of dedicated professionals with a passion for excellence and a commitment to helping our clients thrive in the highly regulated pharmaceutical, cosmetic, and food industries. Our collective expertise spans auditing, compliance, and quality management systems, positioning us as a reliable partner in your journey towards operational excellence.
Qualix services
Quality Audits
Inspection Readiness and GxP Audits
Quality Investigations and CAPA Support
Remediation
Quality Management Systems (QMS) Development and Optimization
Vendor Selection & Management Services
Commissioning, Qualification and Validation
Process Design
Quality Investigations and CAPA Support
Process Qualification
Process Verification
Cleaning and Sterilization Validation
GMP Consulting
Part 11 and Annex 11 Compliance
CSV
Data Integrity
GAP Analysis
GMP Upgrade
Software validation
Excel validation
EXECUTIVE SUMMARY
Qualix Pte Ltd is pleased to submit this proposal to Client, to prepare example costing in GXP, Pharmacovigilance (PV) and Computer System Validation (CSV) audits.
Qualix has significant experience conducting GXP, PV and CSV audits.
Qualix will provide client with fully-trained and experienced auditors who will be able to deliver reports within Client’s required timelines and quality standards.
Delivering Local Expertise Globally
Pharmaceutical, Cosmetic Compliance
At Qualix, we help our clients navigate the complex regulatory requirements of the pharmaceutical and cosmetic industries. Our team of experts provides compliance solutions that ensure our clients’ products meet regulatory standards and are safe for consumption.
At Qualix, we provide Good Manufacturing Practices (GMP) auditing services to the pharmaceutical and cosmetic industries. Our team of experts ensures our clients’ facilities and manufacturing processes comply with GMP standards.
We help our clients establish and maintain effective Quality Management Systems (QMS) that meet regulatory requirements and ensure product quality. Our team of experts provides customized solutions that fit our clients’ unique needs.
What We Do
Qualix has worked for and is a preferred Quality Assurance (QA) provider for, a range of organisations including
small, medium and top pharmaceutical and biotechnology companies.
Consistent & Reliable Services
- Auditing including management of audit programmes
- Quality Management System (QMS) development
- Standard Operating Procedure (SOP) writing and review
- Corrective Action and Preventative Action (CAPA) management
- Inspection readiness and post–inspection support
- In-house support
- Training
- Gap analysis
- General consultancy
