Technology
Advanced facilities, technology, and capabilities to support even the most complex products
Development of Sterile Formulations
We operate to the highest FDA, EMA, and ICH standards, ensuring development work is fully compliant and submission-ready with formulation development services providing the safety, efficacy, and stability of parenteral products across key stages.
Advancing sterile products
We bring deep, end-to-end expertise to every stage of sterile fill–finish development. From solving complex solubility or stability challenges to advancing sophisticated formulations, we deliver with precision and speed, helping your product move efficiently and compliantly toward clinical or commercial success.
Core capabilities
From early formulation through commercial readiness, our integrated approach unites development, manufacturing, lyophilization, and analytical services to accelerate timelines, deliver products to clinic and market, and support even the most complex products with confidence and precision.
- Pre-formulation & Excipient Selection
- Formulation Development
- Aseptic Processes Design & Optimization
- Analytical Method Development & Validation
- Container-closure & Compatibility Studies
- Complete Regulatory Documentation
Lyophilization cycle development
We ensure the stability needed for clinical success through targeted lyophilization development. Using advanced tools such as modulated DSC and freeze-dry microscopy, we generate detailed thermal profiles that guide precise cycle design. Our iterative, data-driven approach refines each cycle to deliver pharmaceutically elegant, stable products ready for clinical evaluation and beyond.
Analytical testing
Stability-indicating analytical methods are central to successful sterile product development. We develop or transfer validated, molecule-specific methods to enable robust characterization throughout development. Our analytical strategy includes comprehensive solubility and stability testing aligned with formulation and process needs, ensuring quality, consistency, and regulatory readiness at every step.
We are inspired by tomorrow
Compliance
Regulatory strength and expert navigation of global pathways with full GMP compliance
Customized
Tailored, client-centric delivery with flexible models and teams committed to your product’s success
Reach
Global network, local Insight, and worldwide support with region-specific expertise
Sterile Development & Manufacturing
Evolution from tech-transfer to treatment, where intelligence, technology, and scalability meet quality, safety, and speed to market
Learn more about our sterile capabilities that deliver quality, innovation, and reliability from development through commercialization.
Contact us today and talk to our expert customer services team about how we can support you with sterile drug development services.