Our on-site team of experts can deliver extensive expertise in quality control (QC) and analytical testing across a diverse array of analytical techniques within the pharmaceutical, biotech, and related industries, encompassing both chemistry and microbiological services. Using our team of expert chemists and microbiologists, we offer comprehensive support in analytical technical services.
OUR SERVICES
CONTRACT QC MANAGEMENT
& ANALYSTS
- Expert analytical support for short and long-term contracts.
- Ideal for situations where full-time positions may not be feasible.
EXPERT
TECHNICAL SUPPORT
- Analytical method troubleshooting and remediation.
- Analytical method validation support.
- Complex issue resolution.
METHOD
OPTIMISATION
- Troubleshooting and optimizing methods for compliance with sample requirements.
- Ensuring suitability for desired sample matrixes
GAP ASSESSMENT
& AUDITING
- Comprehensive gap assessment and remediation services.
- Auditing services and QC-QMS support.
RAW MATERIALS
TESTING AND EVALUATION
Compendial method testing, evaluation, and verification.
FINISHED PRODUCT
QUALITY CONTROL
Batch release testing.
PROJECT MANAGEMENT
& ANALYTICAL METHOD TRANSFER
- Efficient and accurate method transfer during analytical procedure transitions.
- Development of comprehensive transfer protocols and reporting.
- Comparative testing to validate equivalence of methods and test sites.
STABILITY
EVALUATION
- Protocol generation for stability studies.
- Storage, testing, and reporting, following international guidelines.
- Real-Time Stability Studies, Accelerated Stability Studies, Forced Degradation Studies, and Ongoing Stability Monitoring.
TRAINING SERVICES
- Analytical techniques training.
- Troubleshooting and analytical method investigation training.
- Analytical Method Transfer (AMT) training.
- Analytical Method Validation (ICH Q2) training.
- Out-of-Specification (OOS) training.
