1. Product Consistency (Batch-to-Batch Uniformity)
For our customers, reliability begins in the lab. We eliminate variability through validated processes, ensuring that the performance of your final product is never compromised by an inconsistent ingredient.
- API Intermediate Purity: We guarantee Batch-to-Batch Uniformity in chemical composition, impurity profile, and physical properties. Every process step is rigorously controlled to maintain the narrowest possible critical quality attributes (CQAs).
- Herbal Extract Standardization: Our proprietary extraction protocols are validated to ensure the concentration of active markers is identical across all lots. We eliminate the natural variability of botanicals through strict standardization and heavy metal/pesticide testing.
- Process Validation: All manufacturing processes are fully documented, validated, and operated under strict SOPs to guarantee reproducible results, a key pillar of cGMP compliance.
2. Supply Chain Security (Delivery & Sourcing)
We understand that a late shipment or a supply disruption is a critical risk to patient care. Our supply chain is designed for resilience and transparency.
- Global Traceability: We maintain an end-to-end audit trail, ensuring complete traceability for all raw materials—whether synthesized or botanically sourced.
- Inventory Resilience: Through intelligent planning and proactive risk mitigation, we maintain buffer stock and qualified backup suppliers to guarantee a fail-safe supply even in volatile market conditions.
- Logistical Dependability: We partner with specialized logistics providers to ensure products are handled and delivered under the required controlled conditions (temperature, humidity, and light) to maintain product integrity to your receiving dock.
3. Regulatory Dependability (QMS and Documentation)
True reliability means being a partner who is always ready for scrutiny.
- QMS Integrity: Our Quality Management System is built not just for compliance, but for proactive audit readiness with easily accessible, comprehensive documentation packages.
- Data Reliability: We ensure all Certificates of Analysis (CoA), stability data, and process records are accurate, complete, and fully secured, underpinning your confidence in our documentation.
SOLANA LIFE SCIENCES PVT. LTD.: We are the predictable partner in a demanding industry. Our promise is not just quality; it is dependable quality.
