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Sannova analytical Inc. serves the pharmaceutical industry with its efficient team having advanced analytical instrumentation and state of the art facility. Sannova works hand in hand with Innovative, Generic Pharmaceutical and Biotechnology companies through out their NDA and ANDA submissions by performing the following tasks to its clients:
- Robust method development & validations.
- Cost-effective Preclinical and Clinical Sample Analysis.
- BA/BE or PK/TK Data Analysis and Reporting.
- Data Management & Project Management.
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1) Bioanalytical Methods:
Sannova offers rapid method development of LC-MS/MS assays for pharmaceutical compounds and their metabolites in human and animal biological matrices in support of the biostudies. A dedicated team will work on the given project to efficiently develop very sensitive and cost-effective robust analytical methods, which suit for the study. However, quality is always given highest priority and never sacrificed.
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.
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Sannova offers custom method development and tech-transfer services to Sponsors. Besides, with equal ease it institutionalizes Sponsor’s existing methods for sample analysis. On need basis, Sannova also improves and validates Sponsor’s existing methods.
Sannova is specialized in developing and validating unique methods for special analytical needs such as chiral separations and drug-drug interaction etc. |
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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. |
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3) Data Reporting & Electronic Submissions:
Biostudy reports are prepared as per FDA requirements. We also provide documentation in eCTD
format.
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4) Data management:
Strict security and confidentiality policies and procedures are in force to all Bioanalytical work, to ensure that each client receives services of the highest integrity. Features include the following
Fully secured facility, monitoring systems.
Uninterrupted power supply (UPS)- protected laboratory instrumentation.
Fully automated back-up archiving.
Excellent scientist team at Sannova made streamlined procedures and strictly GLP compliant SOPs. |
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Core Strengths
- High quality service.
- Strict adherence to GLP.
- Cost-effective biostudies.
- Complete project management.
- Strict security and confidentiality.
- Electronic submission services.
- Access to clinics in USA, Canada & India.
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Robust Methods for several ther- |
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-apeutic areas. |
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Controlled substance methods |
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(CII-CV). |
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Preclinical and clinical sample an- |
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-alysis. |
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BA/BE studies & PK/TK data ana- |
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-lysis. |
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State of the art equipment. |
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Reports in eCTD format. |
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Access to clinics in USA, Canada& |
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India. |
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Complete project management. |
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Electronic submission services. |
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Strict adherence to GLP. |
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Strict security and confidentiality. |
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Method Development |
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Method Validation |
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Pre clinical & clinical sample ana- |
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-lysis. |
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Report preparation for bioanalyt- |
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-ical studies reporting. |
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Pharmacokinetic & Toxicokinetic |
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Statistics |
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