Safety Testing
SGNCO has safety testing laboratories,
which are maintained with registered and inspected facilities. The
facilities have capacity to provide a selected array of Good Manufacturing
Practice (GMP) and Good Laboratory Practice (GLP) safety studies. Besides
this, SGNCO provides in vitro safety testing, which are validated
alternatives to the conventional methods.
Conventional Tests Include
- Bio-compatibility testing of medical devices
- Geno-toxicity microbial reverse mutation
- Pre-clinical safety assessments
- Acute and sub-acute studies
- Irritation and sensitization assays
- Ames mutagenicity Test
- Hemolysis
- Endotoxin test
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Stability Studies
SGNCO offers complete stability testing
services as per GMP-GLP and ICH guidelines. The services include study
design, analytical testing, monitoring and through documentation.
SGNCO provides complete storage solutions through different climatic
chambers and cabinets. A wide range of refrigerators and freezers is
available for storage at lower temperatures. Besides, we also arrange
specific facilities as per the clients' requirements. These fully controlled
chambers have monitoring and alert systems on 24x7 basis. Our stability
study testing services include:
- Stress tests ? Photostability studies
- Development and validation of stability indicating methods
- Stability-relevant parameters testing
- Storage and management of the stability samples
- Interim and final reports for testing
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Temporary Staffing
SGNCO provides temporary staffing
services to the pharmaceutical companies for clinical trial services. The
outsourcing service for clinical trial specialists meets the actual
objective of any project facilitating the clients to focus on their core
business issues. We provide continuous training to our staff in order to
keep them updated on all facets of the industry. SGNCO temporary staffing
services are applicable when clients:
- Plan for future studies, but currently understaffed
- Need temporary help for a particular time period
- Work to meet a deadline that will not be met otherwise
- Conduct a large trial and need temporary staff
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SGNCO provides temporary staffing for:
- Clinical Research Monitoring
- Project Management
- Clinical Trial Assistance
- Data Management, Review & Entry
- Biostatistics
- Medical Writing
- Regulatory Affairs
- Pharmacovigilance
- Medical Advise services
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Water System Validation
SGNCO provides laboratory-testing
services for the validation of purified water systems, which is a prominent
component in pharmaceutical industry. The validation of water purification
systems is mandatory to insure the production of requisite quality water.
For validation, our technicians collect water samples from clients'
facilities. If the production site is located at different place, samples
are collected through shipment. Afterwards, samples are subjected to
microbiological testing. All the bacterial, endotoxins and chemistry testing
get completed as soon as possible in conformation to USP/EP/JP. We test
water samples for:
- Conductivity
- TOC
- Particulate Matter
- Bacterial Endotoxins (LAL)
- Coliform
- Total Microbial Count
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