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TIDES regulatory dossier
preparation
A deep specialism in regulatory support for complex TIDES projects.
Handling your complex TIDES regulatory needs with meticulous care
Our regulatory dossier preparation services offer specialized expertise for both peptide and oligonucleotide therapeutics, guiding your programs through complex global regulatory landscapes. Our dedicated global regulatory CMC writing teams possess deep experience in preparing comprehensive submission packages for key regulatory bodies worldwide, including the US FDA, EMA, and China NMPA.
We provide end-to-end support, seamlessly integrating regulatory affairs consultation with the entire TIDES discovery, development, and manufacturing process. Our services encompass meticulous data collection, expert section writing, and timely data review, all designed to ensure that your IND, IMPD, NDA, and BLA submissions are precise, complete, and fully compliant.
By leveraging our profound understanding of global regulatory requirements and our integrated CRDMO model, we streamline the preparation of your CMC dossiers, mitigating potential risks and accelerating your journey to regulatory approval for novel oligonucleotide and peptide therapies.
Our expertise
Our expertise in providing regulatory dossier preparation support is validated by a strong track record. Our global CMC writing teams are highly experienced in global filings, having supported 20+ INDs for US FDA and 20+ INDs for China NMPA submissions. We seamlessly integrate CMC dossier writing, which typically takes 6-8 weeks for a US FDA IND, ensuring precise, submission-ready packages for IND, IMPD, and NDA/BLA for both peptide and oligonucleotide therapeutics.
Our quality
Quality is central to every peptide conjugate we deliver. From payload selection to final construct, we apply rigorous analytical controls and method development to ensure accuracy, purity, and consistency.
Our teams approach each project with the precision and care complex conjugates demand. At WuXi TIDES, we don’t just manage complexity – we turn it into confidence, delivering reliable outcomes that support smooth downstream development and the successful advancement of targeted peptide therapeutics.
Our locations
Our global network supports peptide conjugate synthesis with scale, specialization, and regional flexibility. With key facilities across China, Singapore, the U.S., and Switzerland, we offer integrated peptide and conjugation capabilities close to your development hubs.
Each site operates with the same precision and responsiveness – ensuring your complex molecules progress without delay. By combining local access with global coordination, we help you move from idea to breakthrough with confidence and purpose-driven pace.
Our history
From its foundation, our journey has been defined by a commitment to innovation, quality, and strong partnerships, driven by a purpose-driven pace. We’ve evolved into a leading CRDMO with a perfectly orchestrated platform, consistently expanding our global footprint and capabilities to accelerate breakthroughs for our partners and patients worldwide.
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