•  
  • Global CMO
  • Quality Service

서브 컨텐츠

Quality Service

Quality Control/Assuarance
Pharmaceutical Analysis Contract Services

Kolmar 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 Korea. 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, Kolmar will be with you each step of the way.

Mission & duties
Quality Management
Quality Assurance
Quality control
Quality policy
Quality improvement
Quality Management

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
  1. 01. Maximize the performance of quality management by following basic requirements and strengthening the preventive activities.
  2. 02. Meet the client requirements based on the spirit of defect-free production
  3. 03. Secure trust in products and services through constant improvement efforts