Case Studies

Delivering Excellence.

CAPA System - Redesigned

Global manufacturer of solid orals wanted to have their complete Change Control and CAPA system to be redesigned to meet the growing regulatory demands

Label / Artwork Management

Indian co with operations in 27 countries across different geographies was finding it difficult to manage their over 5000 SKUs artwork internally and ensure perfection.

API Vendor Review

A global manufacturer was facing issues with their API manufacturer. Reviewing the entry of a New API Manufacturer while ensuring variation filings were a difficult area to manage.

Life-Cycle Management

Client was stuck with frequent changes, inept data management, broken processes and lack of expertise leading to six-figure revenue loss

New Chemical Entity - ASEAN

Client was unable to make a regulatory filing for a EU origin Drug, for lack of understanding, knowledge and the procedure in ASEAN

Biosimilars

One of the worlds top 15 manufacturers wanted to enter an ASEAN market. They wanted an experienced regulatory partner to file and provide MA Holding & Pharmacovigilance services.

SLA Based Closure

Handling filing for a large Indian conglomerate despite their own local office and team, outsourced and received time bound regulatory approvals in Uzbekistan

Regulatory Filing Strategy

Company with limited outside-EU presence wanted to make a big presence across Asia. Time was of essence.