Customized Raw Material Development
We specialize in tailored API (Active Pharmaceutical Ingredient) and excipient development to meet unique client requirements. Our team collaborates closely with clients to design, synthesize, and optimize raw materials for specific formulations, ensuring compatibility with regulatory standards (e.g., USP, EP). From early-stage R&D to scalable production, we deliver solutions for niche therapeutic areas, bioavailability enhancement, or patent-expired product redesign. Rigorous quality control and documentation support seamless integration into your supply chain.
Technology Transfer & Process Optimization
We streamline technology transfer between R&D and manufacturing phases, ensuring robust scalability and compliance with cGMP/ICH guidelines. Our experts analyze existing processes, identify inefficiencies, and implement cost-effective optimizations (e.g., yield improvement, waste reduction, or solvent recovery). We validate protocols, troubleshoot deviations, and provide full documentation for regulatory submissions. Partner with us to accelerate production timelines while maintaining quality and reducing operational costs.
Audit Services
Our comprehensive audit program evaluates suppliers, CMOs, and internal quality systems against FDA, EMA, and WHO standards. We conduct gap analyses, facility inspections, and documentation reviews to ensure compliance with GMP, GDP, and data integrity requirements. Post-audit, we deliver actionable remediation plans and training to mitigate risks. Trust our independent assessments to strengthen your supply chain resilience and regulatory readiness.
Testing Service
Our laboratories offer end-to-end analytical testing, including identity/purity assays, residual solvent analysis, and microbiological testing. Leveraging advanced techniques (HPLC, GC-MS, NMR), we validate raw material specifications, stability studies (ICH Q1A), and batch-release criteria. Customized test protocols and rapid turnaround times ensure compliance with global pharmacopeias (USP, EP, JP).