FastTrack-to-Clinic Oligonucleotides

The  potential of oligonucleotide therapeutics is extraordinary but so are the complexities that drug developers must navigate to ensure successful drug development. From synthesis to analytical characterization, through safety toxicology and regulatory documentation, success depends on precision, coordination and consistency. 

With FastTrack-to-Clinic we bring everything under one roof. By uniting every capability, we can deliver a submission-ready IND to accelerate your time to clinic.

Our Service Includes:

• API Process Development: Optimized solid-phase synthesis, purification and scale-up strategies to support all the relevant activities
• Analytical Development & Characterization: Comprehensive API characterization and impurity profiling, stability studies and release
• Non-clinical Toxicology: Aligned study design and data integration that eliminates regulatory gaps before they arise
• Regulatory Strategy and Submission Support: From data to dossier, ensuring data consistency to meet global standards

With multifaceted experience in bringing projects through regulatory requirements, if necessary we build a tailored elements to drive your project to regulatory submission. 

FastTrack-to-Clinic programs are tailored to your development stage, funding, and regulatory targets. Our flexible engagement models let you scale support as your project grows.

You’ve built an innovative molecule. Now, partner with a team that unites every capability to deliver a submission that’s fast, compliant, and regulator-ready.

Speak with our oligonucleotide development experts and discover how FastTrack-to-Clinic can accelerate your IND/IMPD submission. Let’s Bring Your Oligonucleotide to the Clinic with Confidence!