Testing Solutions
Testing & Validation Expertise for Pharma, Biotech & Medical Devices
At Ross Biotech, we know every molecule and device comes with unique analytical and microbiological challenges. We provide practical, end-to-end consultation to help you develop robust testing strategies, validate methods, and meet regulatory requirements with confidence.
Our Services
Method Development & Validation
- Analytical methods for APIs, formulations, and raw materials.
- Microbiological and endotoxin testing (USP, EP, JP, ISO 11737).
- Validation protocols, method transfer, and robustness studies.
Pharmaceutical Product Testing
- Sterility, bioburden, and microbial limits.
- Dissolution, assay, stability testing.
- Extractables & leachable study planning.
- Risk-based sampling and optimized test design.
Medical Device Testing & Validation
- Biocompatibility, cytotoxicity, and endotoxin testing (ISO 10993, ISO 11737, FDA).
- Cleanroom validation and environmental monitoring.
- Packaging, sterilization, and accelerated aging studies.
Custom & Complex Studies
- Non-routine or high-complexity protocols.
- Real-world stress and contamination simulations.
- Statistical evaluation for regulatory submissions.
- Partner lab collaborations for specialized analyses.
Why Work with Us
- End-to-End Support: From method feasibility to regulatory submission.
- Regulatory Alignment: USFDA, EU MDR, WHO, and ISO compliant.
- Multidisciplinary Expertise: Pharma, biotech, and medical devices.
- Innovation-Focused: Practical, reliable, and cost-effective solutions.
Partner with us to streamline your testing and validation processes, strengthen compliance, and accelerate product development.