NUTRACEUTICALS
With thorough knowledge on recent regulations on nutraceuticals in the domestic and international market, at Bisavni we understand our client’s requirement with respect to product’s efficacy and safety. Bisavni offers End-to-End customized services based on the claims to support the product to pass through regulatory guidelines and as well as to support in product marketing.
At Bisavni, we optimized the standard protocols to evaluate the Nutraceutical products through the preclinical and clinical research services to confirm the efficacy, safety and quality of raw materials and formulations.
PreclinicalEfficacy studies (In vitro & In vitro)- Antioxidant
- Diabetes management
- Eye Health
- Immunomodulatory & Inflammation
- Hepatoprotective
- Obesity/Weight Management
- Digestive & Probiotics
- Cardio/Heart protective
- Women Health
- Joint & Muscle Health
- Gut Health
- Osteoporosis
Toxicology- Acute oral Toxicity
- Acute Dermal toxicity
- Acute ocular toxicity
- Acute inhalation toxicity
- Repeat-Dose Toxicity Studies (Sub-acute/Subchronic/Chronic)
- Skin sensitization
- Genotoxicity
- AMES test (BRMT)
- Chromosomal aberration in vitro
- Micronucleus assay
Clinical- Feasibility & Regulatory approvals.
- Medical Writing
- Project Management
- Clinical trial and Site management
- Clinical Trial Monitoring
- Clinical Data Management
- Biostatistics
| Quality ControlPhysico chemical analysis- Determination of pH
- Moisture Content Analysis (LOD)
- Disintegration
- Dissolution
- Melting point
- Marker analysis by HPLC
- Friability
- Hardness
- Stability Studies (Real time & Accelerated)
- Bulk density & Tap Density
- Determination Ash Value
- Weight Variation
- Sieve Analysis
- Limit Tests
- Titrations
Microbial analysis- Total aerobic count
- Specific Pathogen detection
- Preservative efficacy testing (PET)
- Sterility testing
- Bacterial Endotoxin Test (BET)
- Water analysis
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