Sannova Analytical Inc (SAI)

Overview

Sannova Analytical Inc. (SAI) is a GXP compliant Bioanalytical Contract Research Organization (CRO) located in central New Jersey, USA.

Sannova's experienced scientists provide Bioanalytical services from the method development and validation through delivery of Bioequivalence/Bioavailability (BA/BE) or Pharmacokinetic/Toxicokinetic (PK/TK) analysis for Preclinical or Clinical studies to Innovative, Generic Pharmaceutical and Biotechnology industry worldwide.

Sannov's well qualified scientists, with more than a decade relevant experience in major pharmaceutical corporations, also offer Statistical Services, Data Management and complete Project Management.

Sannova is on the fast track in its expansion and is the fastest growing Bioanalytical CRO in the pharmaceutical industry.

Standards & Methodologies

1) Bioanalytical Methods: Method validation is carried out in accordance with following guidelines: United States Food and Drug Administration (FDA). Organization for Economic Cooperation and Development (OECD). As per the Standard Operating Procedures (SOPs) of Sannova and/or Sponsor.

2) GLP Bioanalysis: Latest equipment with automated technologies for high throughput LC-MS/MS analyses enables Sannova to support as simple as a pilot study to a full-fledged pivotal study. The criteria for acceptability of an assay are stringently adhered in accordance with Sannova SOPs, which were based on FDA?s guidance for Industry on Analytical Procedures and Methods Validation.

3) Data Reporting & Electronic Submissions: Biostudy reports are prepared as per FDA requirements. We also provide documentation in eCTD format.

Qualifications, Certifications, Accreditations & Licenses

You can be assured that when your studies are conducted by Sannova they will be performed in full compliance with GLP, GMP & all appropriate regulations. FDA compliant Bioanalytical Contract Research Organization (CRO)