GLP GCP GLP
 
       
Bioanalytical Laboratory Bioanalytical Laboratory Bioanalytical Laboratory Bioanalytical Laboratory Bioanalytical Laboratory

 

GCP
GCPGCP
GCP GLP GCP GCP
 
 
  Bioanalytical laboratory
 
 
Sitec labs making Bioanalytical laboratory fluorescence electrochemical Pharmacy Bioequivalence GCP GLP Phlebotomy stations Therapeutic drug
GLP
Sitec labs making Bioanalytical laboratory fluorescence electrochemical Pharmacy Bioequivalence GCP GLP Phlebotomy stations Therapeutic drug
GLP
Bioanalytical laboratory
Bioanalytical laboratory
Bioanalytical laboratory
GCP
Bioanalytical laboratory
fluorescence fluorescence fluorescence fluorescence fluorescence
fluorescence fluorescence fluorescence fluorescence fluorescence
 
 

LABORATORIES

GCP
 

The Bioanalytical laboratory is equipped with latest models of GCs and HPLCs with auto injectors and UV-VIS, fluorescence, electrochemical, refractive index detectors and LC-MS/MS etc.

Clinical section: 
It consists of:

  • Ward of 30 beds.
  • ICU.
  • Doctor’s work station.
  • Volunteer screening section.
  • Phlebotomy stations.
  • Pharmacy.
  • Sample processing rooms.
  • Recreation center.
  • Pantry and Cafeteria.
  • Sample storage area.
  • Sophisticated softwares like WinNonLin & SAS.

Bioanalytical section:
It consists of:

  • Sample processing section.
  • HPLC with various detectors including MS-MS like API 365, 2000, 3000 (2nos), 4000 (2nos).
  • Other automated instruments for sample processing.
  • Method development, Method validations and documentations to ICH guidelines.
  • Data management system.

Services such as:

  • Bioequivalence evaluations of generic products.
  • Dose proportionality bioavailability studies.
  • Therapeutic drug monitoring.
  • Evaluation of new drug delivery systems.
  • Food effect studies.
  • Evaluation of controlled and extended release dosage forms.

Quality Assurance:
In compliance with the GCP and GLP guidelines, in-house quality assurance audits are routinely performed for the facility, systems and individual projects. A quality audit plan is drawn to ensure that the data are of consistent quality.

   
 
 
   
 
 
GCP