Regulatory support
At Sylentis, we understand that regulatory success begins long before submission. With direct experience authoring regulatory dossiers for both the FDA and EMA, we offer a unique advantage: we integrate regulatory writing into the development and manufacturing process. This means that by the time your API is ready, your CMC dossier is too—saving you time, reducing risk, and accelerating your path to clinic or market.
Our capabilities
CMC dossier authoring for FDA, EMA, and other global regulatory agencies
Integrated regulatory writing during development and manufacturing
Gap analysis and remediation of existing documentation
Support for IND, IMPD, and NDA/MAA submissions
Regulatory strategy consulting for oligonucleotide-based therapeutics
Response preparation for regulatory agency questions
Phase-appropriate documentation aligned with clinical milestones
Collaboration with your regulatory team or full-service support
Let’s work together
Sylentis is more than a CDMO—we’re your regulatory partner. With hands-on experience and a proactive approach, we help you navigate complex requirements and deliver complete, submission-ready documentation alongside your product.
Contact us today to learn how our regulatory expertise can streamline your development and accelerate approvals.