QbD-Driven Development
Quality-by-Design ensures time-efficient, hassle-free regulatory submissions with robust CMC packages.
Pharma R&D · CDMO · Clinical Services
A trusted partner for oral dosage forms and injectables — from concept through regulatory filing and commercial supply. Built on rigorous science, disciplined GMP, and a dedicated oncology capability.
From concept to commercial supply.
Integrated pharmaceutical services with quality, speed, and regulatory compliance at every stage — giving our clients one trusted partner across the drug development lifecycle.
View all servicesQbD-driven formulation of oral solids and liquids — from pre-formulation through prototype to scale-up readiness.
Learn moreSterile and non-sterile injectable formulation — solutions, suspensions, lyophilized products, and peptides.
Learn moreMethod development, validation, stability, and routine QC analysis to US FDA / EU EMA standards.
Learn morePilot, BE, pre-clinical, clinical and commercial-scale GMP manufacturing for oral and injectable products.
Learn moreSeamless knowledge transfer from R&D to pilot or commercial scale, with full documentation and PM oversight.
Learn moreA fully segregated, containment-compliant lab dedicated to anti-neoplastic oral and injectable formulations.
Learn moreOne partner. Reduced complexity.
Quality-by-Design ensures time-efficient, hassle-free regulatory submissions with robust CMC packages.
Small-scale batch capability minimises API and raw material costs without compromising quality or compliance.
Quick turnaround through an effective PM team — urgent batches handled with speed and precision.
End-to-end capability from early research through commercial manufacturing — one partner, reduced complexity.
A separate, segregated facility dedicated exclusively to anti-neoplastic formulations.
Deep US FDA & EU EMA experience with robust CMC, pharmacovigilance and regulatory submission support.
Get in touch
Whether it's an early-stage formulation challenge, a 505(b)(2) program, or a commercial tech transfer — we'd be glad to talk through how we can help.