Precision manufacturing and regulatory mastery for the world's most demanding pharmaceutical companies. From raw materials to finished dose forms, we deliver excellence at every stage.
Three core capabilities. One standard of excellence. Every product engineered for regulatory success.
Compendial-grade excipients and processing aids with complete traceability and comprehensive certificates of analysis.
Custom synthesis and scale-up under ICH Q7 with validated processes and rigorous quality control.
Oral solid dose and topical formulations with integrated packaging, labeling, and serialization.
Quality engineered from the ground up. Every process designed for regulatory success and audit readiness.
Our quality management system integrates seamlessly with your development timeline, ensuring speed and compliance advance together.
End-to-end capabilities engineered for pharmaceutical precision. From development to delivery.
Route optimization and risk mitigation with scale-up readiness built in from day one.
Cleanroom facilities with integrated analytics and real-time process control.
Validated methods for release testing, stability, and regulatory submissions.
Integrated labeling, tamper-evidence, and DSCSA-compliant serialization.
Temperature-controlled distribution with continuous monitoring and validation.
Seamless handoffs with comprehensive documentation and training protocols.
Documentation engineered for regulatory success. Clear, comprehensive, and aligned with global agency expectations.
Complete chemistry, manufacturing, and controls packages for global submissions.
Comprehensive impurity characterization and qualification studies.
ICH-compliant stability studies with statistical analysis and shelf-life determination.
Analytical method development and validation per ICH guidelines.
US DSCSA and EU FMD serialization with full data integrity.
FDA, EMA, and Health Canada submission support with regulatory intelligence.
Exceptional execution under pressure. Regulatory-ready from day one.
Audit-ready documentation that anticipated every agency question.
Launch timeline achieved without compromising quality standards.
