BCI has extensive
experience preparing all types of major regulatory submissions, including
complex multinational submissions. BCI can provide review of each
submission for verification of compliance with applicable guidelines
and for potential refusal-to-file issues. BCI can provide these services
as part of the client’s internal project team or as a stand
alone service. With offices in North America and Asia, and offices
opening soon in Europe, BCI global regulatory affairs team is an
experienced and skilled in the coordination and preparation of global
regulatory submissions. These global regulatory submissions include:
- Abbreviated new drug applications (ANDA)
- Biologics license applications (BLA)
- Clinical trial authorization/application/exemptions (CTA/CTX)
- Clinical trial notifications (CTN)
- Common technical document (CTD)
- Drug master files (DMF)
- Fast track applications
- Investigational drug exemptions (IDE)
- Investigational new drug applications (IND)
- Marketing authorization applications (MAA)
- New drug applications (NDA)
- New drug submissions (NDS)
- Orphan drug applications (ODA)
- Premarket approvals (PMA)/510(k)s
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