CMC & Regulatory Support

LOTTE Biologics provides CMC and regulatory support throughout the product lifecycle.
From IND/BLA submissions for early-stage programs to lifecycle support for commercial products, we help clients address regulatory requirements and
submission needs.

Common Technical Document
(CTD) Authoring

CMC Section Authoring for
CTD Submissionst

Chemistry, Manufacturing, &
Controls (CMC) Strategy Alignment

Cross-Functional CMC
Strategy Alignment

Submission Support

CMC Documentation Review and
Submission Support

Response Support

Regulatory Authority
Response Support

Inspection Readiness

Pre-Approval Inspection (PAI) Readiness
& Support

Drug Master File (DMF)
Maintenance

Type V DMF Maintenance for Regulatory
Submissions

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