Regulatory: Clear your path from concept to candidate
Partner with us and leverage our deep wide-ranging scientific expertise and proven track record in regulatory support from development through commercialization. Curia’s decades of experience navigating the complex global regulatory landscape gives you a head start, and can help shorten your time to market.
Our track record for quality is proven with through compliance with the main WW regulatory agencies like FDA, EMA, PMDA, CDE, Korean FDA, ANVISA…., and more than 550 API DMFs filed worldwide. Whatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.
Support
Whatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.
- Global filing support
- CMC module authoring (drug substance and drug product)
- Certificate of Suitability (CEP)
- Pre-IND and pre-NDA/ANDA meetings, Type C meetings, etc.
- Consulting and deficiency management
- Site registrations, U.S. Agent services
- Publishing services (eCTD)
Specific support linked to DEA / Controlled Substance:
- DEA registrations
- DEA consulting
- Quota requests
- Determination requests
- Researcher protocols
Specialized regulatory support
Diverse program experience across emerging and established modalities, such as mAbs and mRNA, demanding specialized and complex regulatory support.
Collaboration
Integrated teams between small molecule and biologics leveraging each other’s expertise and global regulatory authority relationships.