Regulatory filings are a crucial step towards market approval, supplying important information about the drug’s safety, efficacy, quality, and manufacturing process. As one of the most experienced CDMOs in the therapeutic oligonucleotide industry, you can rely on our regulatory expertise, quality assurance teams, technical support, and post-approval support to help you navigate the complex regulatory landscape. Driven by our technical and regulatory experience, we provide support for CMC sections of the regulatory submission.
Our experts help you navigate a constantly changing regulatory landscape.
Speed up time to clinic and market approval
Benefit from decades of experience in the therapeutic oligonucleotide space
Extensive experience with global regulatory authorities (PMDA, FDA, EMA, ANVISA, etc.)
Dedicated regulatory team assigned to your project
Regulatory Support Services
Authoring of regulatory documents, review of filings before submission (IND, IMPD, NDA, MAA, J-NDA, BLA…)
Preparation for Scientific Advice meetings
Assistance with risk assessments (e.g., nitrosamine risk assessments)
