FDA compliant Bioanalytical Contract
Research Organization (CRO)
 
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.Professional service
.Meet Deadlines
.Cost-effective Budgets
  
 
     
   
 
  • Applied Biosystems API 5000 and API 4000 LC/MS/MS Systems
  • Shimadzu HPLCs with UV visible and PDA detectors
  • Freezers, -20, -70
  • Automated dispensers and micro pipettes
  • Solid phase and Liquid-liquid extraction capability
  • Mettler balances
  • Centrifuges
  • Solvent evaporators
  • PH meters
  • Sonicators
  • Ovens
  • Fume hoods and SPE work stations
Software:
  • Analyst 1.5 and 1.4.2 software- compliance to 21 CFR part 11
  • SAS 8.2 software for Biostatistics
Core Strengths:
  • Qualified as per FDA and ICH requirements.
  • Qualified and Trained man power.
  • Strict adherence to GLP.
  • Cost effective and Highly sensitive methods.
  • Experience in Method Development for Multi Component Analysis using single methods. 
  • Complete Project Management.
  • Focused on Customer Service and Satisfaction.
  
sannova
 
sannova
 
  Equipments:
  • Applied Biosystems API 4000 LC/MS/MS  systems.
  • Shimadzu HPLCs with UV VIS & PDAs.
  • Freezers -200c, -800c.
  • Mettler Balances and pH Meters.  
  • Refrigerated Centrifuges and Sonicators.
  • Automated Dispensers and Micro Pipettes.
  • Solid phase and Liquid-liquid Extractors.
  • SPE Workstations and Solvent Evaporators.
  • Ovens and Fume Hoods.
 
 
 
 
     
 
    
Robust Methods for several ther-  
  -apeutic areas.  
Controlled substance methods  
  (CII-CV).  
Preclinical and clinical sample an-  
  -alysis.  
BA/BE studies & PK/TK data ana-  
  -lysis.  
State of the art equipment.  
Reports in eCTD format.  
Access to clinics in USA, Canada&  
  India.  
Complete project management.  
Electronic submission services.  
Strict adherence to GLP.  
Strict security and confidentiality.  
 
 
    
Method Development  
Method Validation  
Pre clinical & clinical sample ana-  
  -lysis.  
Report preparation for bioanalyt-  
  -ical studies reporting.  
Pharmacokinetic & Toxicokinetic  
  Statistics  
   
Contact Us :-

 (732)560-0066 		 
 
 
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