Quality Assurance & GMP Compliance
At Vubrix Pharma, quality is non-negotiable. We maintain world-class quality management systems, GMP certification, and regulatory alignment to deliver APIs and intermediates that meet the highest standards.
Certifications & Standards
Our facilities and processes comply with international quality and regulatory standards.
GMP Certified
Good Manufacturing Practice certified facilities for API and intermediate production.
ISO 9001:2015
Quality management system certified for consistent processes and continuous improvement.
FDA & EMA Aligned
Documentation and processes aligned with US FDA and European EMA requirements.
USP/EP/BP Grade
Products meeting United States, European, and British Pharmacopoeia standards.
Quality Control Laboratory
Our state-of-the-art quality control laboratory performs comprehensive analyses using validated methods and advanced equipment including HPLC, GC-MS, NMR spectroscopy, and dissolution testing.
- Raw material testing and qualification
- In-process testing at critical stages
- Final product analysis and release
- Stability studies (ICH guidelines)
- Method development and validation
- Impurity profiling and identification
Regulatory Documentation
We support our customers with comprehensive regulatory documentation for global submissions.
DMF Support
Drug Master File preparation and maintenance for US FDA submissions. Type II DMF for APIs and intermediates.
CTD Modules
Common Technical Document (CTD) support for European EMA and other international regulatory agencies.
COA & MSDS
Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) with every shipment. Full traceability and batch records.