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Contract Analysis
SANA Pharma and through it qualified lab is ready to provide physical, chemical, and microbial analytical services for pharmaceutical, food and cosmetic products for the purpose of product release, regulatory requirements as well as accredited third party arbitration. These services include:
- Impurity profiling
- Stability indicating method development and method validation
- Stability protocol preparation, analysis, and monitoring
- Assigning shelf life
- Microbial count testing
- Microbial contamination testing
- Preservative effectiveness testing
- Sanitizers challenge testing
- Water microbial and chemical testing
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Formulation & Development services:
- Prototype formulation development
- Scaling – up formulation
- Process optimization
- Product development reporting
- Documentation in CTD format
Cosmetics Safety and efficacy studies:
Sana Pharma is willing to assist the cosmetic industry in development of a scientific evaluation of cosmetic’s products.
It takes advantage of the use of modern instrumentation to give a quantitative result as wells as of qualitative clinical evaluation. These results are achieved through the collaboration with the support of a qualified staff including dermatologist, biologist t, chemist and toxicologists covering a broad range of know how.
Working with university’s structures, cellular culture facilities and analysis laboratories, Sana Pharma has built an effective net work of top-qualified investigators.
All the evaluations are carried out on healthy volunteers or in vitro using cellular culture.
Sana Pharma for cosmetic industry Services includes:
- آ�Safety tests: Sun protection factor Determination (SPF)
- Water resistance evaluation
- Patch test (irritation test)
- Effectiveness of wrinkle-preventing, sebum-balancing, opacifying, whitening, anti-dandruff, moisturizing products and so on.
- In vitro test (Safety and Efficacy of cosmetics)
In vitro tests are an interesting replacement to the animal experimentation. Through this tests is possible obtain information about safety and efficacy of finished products. In vitro tests give, in the development phase, a fast screening of the raw materials, and the cosmetic formulator can select the best active for his product.
Sana Pharma in vitro test includes:
- Ocular irritation (NRU assay)
- Red Blood Cell test (RBC assay)
- Oxygen consumption
- Protein synthesis
- Cells growth
- Antioxidant efficacy (anti-ROS) on keratinocytes and fibroblasts culture
- Cytotoxicity (MTT assay)
- Diffey test (critical wavelength test)
Bioequivalence studies:
SANA Pharma, through its pharmacokinetic expert, provides the service of reviewing and approval of bioequivalence studies protocols and reports as well as statistical analysis and evaluation of biostudies. Thanks to its quality assurance system, SANA Pharma is able to provide quality assurance system for monitoring and auditing bioequivalence studies as third party
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Toxicity Studies:
SANA Pharma is capable to conduct acute, sub acute, and chronic toxicity studies for different dosage forms. The study protocol will be according OECD European guideline.
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Pharmacodynamicآ� Studies:
Screening and evaluation of herbal extracts and non-herbal molecules for potential active constituents on molecular, cellular and in vivo models.
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