Analytical Chemistry
SGNCO offers analytical chemistry testing
services that are designed for validating quality control processes in
pharmaceutical industry. These services are extended to the analytical
controls for raw materials, finished products and packaging materials.
We strictly follow quality control parameters that are compliant to EP, USP,
BP, JP etc. With our own state-of-the-art laboratories, we conduct the
following physicochemical tests:
- Active ingredients identification
- Identification of impurities
- Physical values
- Residual solvents
- Water sampling and analysis
- Various technical processes
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Bioanalysis
SGNCO provides bioanalysis for
pharmaceutical and biotech companies. The company has expertise to support
large-scale routine sample analysis for both pre-clinical and clinical
studies. Our complete bioanalytical services include:
- Method development & validation
- Immunogenicity testing and analysis
- Pre-clinical development
- Post marketing clinical trials
- ADME
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Biostatistics
SGNCO offers biostatistics services,
which analyze and measure the efficacy of any study designed for clinical
trial development. This, ultimately, enhances the quality of the resulting
data. SGNCO has a team of experienced statistician, who work in close
coordination with the clients in order to develop the optimal protocol as
per the desired objectives.
First of all, we develop statistical analysis plan (SAP) after consulting
the clients. This is followed by the analysis in accordance with EMEA,
ICH-E9, ICH, FDA etc. The report of the clinical research is then prepared
underpinning important tables, listings and figures.
Services Offered in Biostatistics
- Preparation of statistical study report
- Statistical consultancy
- Interim analysis
- Comprehensive analysis of clinical and epidemiological trials
- Review of the research report
- Interim analysis for the data safety
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Cell Line Characterization
SGNCO has a team of qualified
professionals, who are well adept at using nucleic acid and protein based
technologies to characterize and identify cell lines. All the testing
procedures are carried out as per the ICH guideline Q5B.
Our analysis establishes correct coding sequence of the product, which is
incorporated into the host cell. The analysis is maintained through the
culture till end production stage. We employ the following test methods:
- DNA fingerprinting & sequencing
- Quantitative PCR
- Histocompatibility antigens
- Isoenzyme analysis
- Safety test for infective adventitious
- Tumorigenicity test
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