FDA compliant Bioanalytical Contract
Research Organization (CRO)
 
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.Professional service
.Meet Deadlines
.Cost-effective Budgets
  
 
     
   
  Quality is the single most important component of Sannova’s analytical services. Quality, excellence, uniformity and discipline are integrated into our systems for all the work done at Sannova.

1) Quality Assurance department:

Sannova’s independent quality assurance (QA) unit assures the highest standard quality data for all projects conducted.
QA unit adopted uniform quality systems in compliance with applicable GLP regulations of the following agencies.
  • United States Food and Drug Administration (FDA)
  • Organization for Economic Cooperation and Development (OECD)
Sannova’s QA unit will always stay current on regulatory trends and keep the pace with Industry compliance standards.

2) GLP Compliance:

Sannova conducts all projects within the guidelines of GLP principles. QA unit performs the following functions:
  • Active phase Inspections of the studies
  • Study specific Inspections
  • Process based audits, which include audits of controls in place that ensure SOPs are constantly followed
  • Facility audits
  • All study inspections against an extensive set of Sannova’s or client specific standard operating procedures (SOPs) to ensure consistent and reproducible data
  • Continuous evaluation and updating of SOPs to reflect evolving technology.
 
  3) Confidentiality :

Strict security and confidentiality policies and procedures are in force for all bioanalytical work done at Sannova to ensure that each client receives services of the highest integrity and value.		  
     
 
    
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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