Regulatory Support
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 FDA, EMA, PMDA and other regulatory agencies and more than 550 API dossiers filed worldwide.
Whatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.
Regulatory Service Offerings
- Global filing support
- CMC module authoring (drug substance and drug product)
- Certificate of Suitability (CEP) authoring and maintenance
- Pre-IND and Pre-NDA/ANDA meetings, Type C meetings, etc.
- Consulting and deficiency management
- Site registrations, U.S. Agent services
- Publishing services (eCTD)
DEA / Controlled Substance Service Offerings
- DEA registrations
- DEA consulting
- Quota requests
- Determination requests
- Researcher protocols