Lab Testing Services
FDA-Registered cGMP Lab Testing for Pharma, Biotech & Compounding Facilities
Quality and compliance are at the core of everything we do. Xseer Pharma maintains a rigorous Quality Assurance/Quality Control (QA/QC) program to ensure all activities meet or exceed current Good Manufacturing Practice (cGMP) standards. Our FDA-registered 503B facility operates under strict standard operating procedures, and we continually invest in quality systems (including 21 CFR Part 11 compliant data management) to support regulatory requirements.
Every batch we produce is thoroughly tested and documented, providing our clients with complete data packages ready for regulatory review. By partnering with Xseer, you gain the confidence that your project is backed by an organization committed to the highest level of regulatory compliance and product quality.
Service Categories:
- Analytical Chemistry
- Microbiological Testing
- Stability Studies
- Specialized Testing
- Regulatory Support
- Potency assay (HPLC, UPLC)
- Impurity profiling & residual solvents (GC/UV)
- Water content (Karl Fischer)
- pH and osmolality (USP <791>, <785>)
- Raw material identification (FTIR, UV-Vis)
- Stability-indicating method development
- Sterility testing (USP <71>, rapid methods)
- Endotoxin testing (LAL, USP <85>)
- Bioburden (USP <61>)
- Pathogen detection (USP <62>)
- Antimicrobial Effectiveness (USP <51>)
- Environmental monitoring (air, surface, gowning)
- Water testing (USP <1231>, TOC, conductivity)
- ICH Q1A-compliant long-term & accelerated storage
- Pull-point testing: potency, sterility, visual inspection
- Freeze-thaw studies
- In-use stability evaluations
- Container closure integrity (CCI – dye ingress, USP <1207>)
- Particulate matter (USP <788>)
- Visual inspection (USP <790>)
- Total Organic Carbon (TOC)
- Filter integrity testing
- Gowning qualification and cleanroom support
- Method development & validation (Phase I–III, commercial)
- Method transfer & verification
- CMC support for IND/NDA/ANDA/BLA
- Data package assembly (validation, stability, CoAs)
Industries We Support:
- 503A & 503B Compounding Pharmacies
- Biotech (preclinical & clinical phase)
- Generic & Specialty Pharma
- Medical Device & Combination Products
Turnaround Times Summary
| Test | Standard TAT | Rush Option |
|---|---|---|
| Sterility | 14 days | 7 days (Rapid) |
| Endotoxin | 2–3 days | 24 hours |
| Stability Pull | 3–5 days | Priority slot |
Trust & Compliance Statement
All testing is performed in our FDA-registered, cGMP-compliant laboratory. Methods are validated to USP, ICH, and FDA standards. All results are QA-reviewed and delivered in audit-ready format (21 CFR Part 11 compliant).
