Quality Control/Assuarance
Pharmaceutical Analysis Contract ServicesWonderful Capital Biotechnology Group Quality responsible persons can provide support for all phases of your drug development, from early stage preclinical method development/sample analysis, post-commercialization, Importation product testing to Australia. Our testing is completed in compliance with all appropriate regulations (cGMP, GLP), and we welcome projects
which are analytically challenging. We believe strong lines of communication between our business and yours are essential to
the successful completion of projects, and we will customize our approach to meet your unique demands. From your initial
inquiry to the final report, Wonderful Capital Biotechnology Group will be with you each step of the way.
Mission & duties
- Quality Management
- Quality Assurance
- Quality control
- Quality policy
- Quality improvement
Pharmaceutical Analysis Services include:
- Drug Development Services
- NDA, IND and QC stability program support
- Method development and validation
- Forced degradation studies
- Final product release testing
- Comparator testing
- Dosing solution analysis
- Compendial testing
- Stability storage on site
- Dosage Forms Analyzed
- Oral Solids (tablets, hard/soft capsules)
- Liquids (external use and Internal use)
- Semi-solids ( ointment, cream, gel )
- Suspensions (powder, granule)
- Testing Capabilities
- HPLC(High Performance Liquid Chromatography)
- - UV/Vis
- - RI detector
- - Fluorescence
- TLC ( Thin Layer Chromatography)
- NIR (Near Infra-Red)
- GC with headspace capability
- Dissolution testing
- Most standard analytical tests
- AA Spectrophotometer(GFA)
- Benefits
- Strong technical staff
- Scientist-to-scientist communication promotes partnering
- Quality data delivered to meet timelines
- Project flexibility
- Program size : Single sample analysis to multi-faceted stability program
- Final report format : C of A, stability table or client defined, all with option of electronic format with electronic signatures
- Methods used : Compendial, Kolmar-developed or client- supplied
- Quality
- Robust QC/QA data review
- Client on-site audits always encouraged
- GMP KFDA inspection — Every 2 year regularly, as required.
- GMP-compliant
- GMP Audit Certificate
Quality Contribution
- 01. Maximize the performance of quality management by following basic requirements and strengthening the preventive
- activities.
- 02. Meet the client requirements based on the spirit of defect-free production
- 03. Secure trust in products and services through constant improvement efforts