Inspection Services
SGNCO offers its services to examine
pharmaceutical and medical products. Our experts carry out visual inspection
to ensure the compliance of the products with international regulations or
any pre-defined specification. Additionally, the consignments are inspected
to negate any defect or damage. The following services are offered in
inspection services:
- Sample preparation and quality checks
- Shipment inspection during loading/unloading
- Inspection and verification of delivered consignments
- General QC checks
- Pre-production inspection of raw materials
- Supervision of container loading
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Medical Affairs and Pharmacovigilance
SGNCO offers comprehensive solutions for
safety and risk management for medicinal product. Our multi-disciplinary
team of professionals offer:
- Tailor-made drug safety solutions to SMEs
- Outsourcing of drug safety functions
- Quality system assurance as per international regulations
- Training, consultancy and education
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SGNCO's drug safety experts provide effective solutions in early stages and
later phase of clinical research to meet safety requirements. Our medical
affairs services include:
- Set-up and maintenance of the global safety database
- Emergency management
- Annual Safety Report writing
- Complete medical monitoring
- Report writing (annual, periodic, summary, updates etc.).
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In the post-marketing services, SGNCO ensures continuous monitoring of
quality and efficacy of the marketed products. In case of adverse drug
reactions, we report to the authorities so that our clients avoid setbacks
in their brand reputation.
Medical Device Testing
SGNCO offers a wide range of testing
services to medical device industry. The company has a chain of accredited
laboratories, which are well equipped to check the safety of medical
devices. We also carry out microbiological testing on medical products
before/after sterilization and toxic residues development during
sterilization process. SGNCO's medical device testing services include:
- Sterility testing
- Determination of bio-burden as well as bacterial count before
sterilization
- Bio-compatibility
- Hygiene monitoring
- Cytotoxicity testing
- Test for endo-toxins and ethylene oxide residue
- Implantation test
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Medical Writing
SGNCO provides medical writing services
for the preparation of clinical research reports and similar matters. The
company has a team of experienced writers, who have years of experience in
medical writing. The team of writers works with the clients for developing
report templates as per their requirements.
After the writing part is over, there is a team of Quality Control Experts,
who review the report. At each stage of working, we follow stringent quality
control norms. Once the final report is prepared, it is send back to the
clients for approval. Our medical writing services include:
- Clinical research reports and appendices
- Publications
- Investigator brochure Clinical trial protocol
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Method Development and Validation
SGNCO develops analytical protocol and
reports for the proprietary and non-proprietary testing methods and
manufacturing processes. The company has expertise in developing and
validating various methods for raw materials as well as finished goods.
All our methods and processes are in compliance to the guidelines provided
by ICH (Q2A, Q2B) and FDA. Besides, SGNCO provides assistance in several
method transfers including comparative testing, co-validation between labs,
complete or partial revalidation and complete documentation.
Method Development
- Identification
- Assay testing
- Testing for impurities
- Microbial testing
- pH values
- Oxidative and reductive stress
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Method Validation Services
- Accuracy
- Precision
- Specificity
- Detection & quantitative limit
- Linearity
- Robustness
- Suitability
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