Regulatory CMC Change Control Simulator

Simulate pharmaceutical manufacturing changes, calculate variation classifications, and determine eCTD Module 3 filing impact in seconds.

Select a Proposed CMC Variation

Explore how changes in synthesis, manufacturing facilities, or specifications impact regulatory submissions.

Active Variation Assessment

Relocation of aseptic filling and lyophilisation operations to an alternate EU/US GxP-inspected facility.

Official Classification

Variation Type II (Major)

Target Timeline: 60 to 90 Days Clock

Impacted eCTD Module 3 Sections

3.2.P.3.1 (Manufacturer)

3.2.P.3.3 (Manufacturing Process)

3.2.P.3.5 (Process Validation)

3.2.P.8.1 (Stability Summary)

Mandatory Stability & Analytical Data

3-6 months accelerated & long-term stability data from minimum 3 consecutive commercial scale batches.

Conforms strictly with ICH Q1A(R2) stability testing and ICH Q5C biological product standards.

Reference: European Commission Variation Guideline (2013/C 223/01) and FDA 21 CFR 314.70.Discuss Your CMC Requirements