We are committed to delivering high-quality products to patients across the globe. The presence of strong governance systems and review mechanisms to ensure quality control enables us to maintain compliance with stringent regulatory requirements across our product portfolio.
At Symphony Formulations We Follow
Formulation
Development
Developing stable and consistent dosage forms with uniformity, bioavailability, and performance.
Compatibility studies between API and excipients are key for quality.
Process Development and Optimization
Safe and reproducible manufacturing processes are developed in the R&D phase.
Pilot studies and scale-up batches help confirm consistent quality.
Regulatory
Compliance
ICH Guidelines: Adhering to ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) to support a quality- and safety-centric development.
GxP Compliance: Ensuring R&D processes comply with GLP, GCP (Good Clinical Practice), and GMP (Good Manufacturing Practice) when applicable.
Risk Assessment and Management: Continuous risk assessment helps anticipate and mitigate potential safety concerns early in development.
Raw Material and Supplier Quality
Qualification of Materials: Testing and verifying identity, purity, and quality of R&D materials.
Vendor Audits: Ensuring raw material sources meet quality and regulatory standards.
Continuous Improvement: Lessons learned from post-marketing surveillance (pharmacovigilance) feed back into R&D to improve future product safety.
Safety Assurance in R&D
Identification and control of impurities, including genotoxic and mutagenic impurities.
Safety thresholds are defined per ICH M7 guidelines.
Stability studies under ICH conditions (temperature/humidity) to assess product shelf life and degradation.
Evaluating how excipients impact the API’s quality and stability.