Delivering A Complex Softgel Programme For US Market Supply

Transferring an established softgel manufacturing process across continents is challenging. Doing it on an aggressive timeline while installing new technologies and meeting US market requirements raises the stakes considerably. A multinational pharmaceutical company needed a Trade Agreements Act-compliant manufacturing partner capable of reproducing its registered process without altering critical parameters.

The programme required six new assets to be procured, installed and qualified alongside equipment qualification, QC method transfer and registration batch manufacture. When a critical asset arrived five months late and damaged, close coordination and practical problem-solving helped protect the schedule. Registration batches were manufactured as planned, with stability data generated in line with submission timelines.

Discover how integrated manufacturing and packaging capabilities, direct access to technical experts and regular communication supported rapid decisions throughout this complex transfer. The case study offers practical insight into managing risk, alignment and momentum when timing, compliance and execution must remain tightly connected.