We have well equipped laboratory with modern analytical instrumentation supported by highly qualified lab technician and scientists.
Quality is our highest priority. Our quality department consist of quality control, quality assurance and validation to ensure that the product manufactured in our facility are of highest standard and comply with the cGMP rules and regulations.
To achieve our objectives, We have developed a system of Standard Operating Procedures (SOPs), report formats, and review mechanisms for all areas of the laboratory. SOPs are available for all laboratory functions including but not limited to:
Laboratory Policies and Procedures
• Purchasing
• Sample Receiving and Log-In Procedures
• Maintenance and Security of samples throughout the Laboratory System
• Performing of analytical Methods of Analysis
• Instrument Maintenance
• Document Control Procedures
• Data Management and Handling, including data security and archiving
• Method Compliance, Report Preparation and Data Validation
Analytical Research and Development Team:
With experience of development and validation of all laboratory analytical methods for pharmaceutical drug substance, drug products, and formulation developments.
With experience of isolation and identification of pharmaceutical impurities and synthetic NCE’s for molecular structure elucidation, and new drugs.
With experience of IND, NDA, ANDA filings with FDA and CMC preparation for new drug applications.
With hand-on working experience in analytical instruments: HPLC, GC, Prep-HPLC, UPLC, LC/MS, FTIR, NIR, NMR, and related instrumental software: Empower, Chemstation, Masslynx..