Overview

A European medium-sized pharmaceutical company aimed to streamline its regulatory processes by adopting a strategic outsourcing model for key functions, including Chemistry, Manufacturing, and Controls (CMC) strategy authoring, Electronic Common Technical Document (eCTD) publishing, and submission.

They aimed to achieve efficiency gains and cost savings while allowing internal regulatory teams to focus on high-level, strategic tasks.

Challenges

The client faced substantial regulatory demands due to the complexity of maintaining a large portfolio across global markets:
High volume of regulatory submissions: Managing the workload was increasingly resource-intensive with over 35 marketed products and hundreds of post-approval changes annually.
Global compliance requirements: The client required a partner capable of delivering consistent, high-quality CMC authoring and eCTD publishing while ensuring compliance with global regulatory requirements.

G&L’s Approach and Solution: 

G&L implemented a comprehensive outsourcing solution tailored to the client’s regulatory needs. The approach was designed to maximize efficiency and minimize operational disruptions, including:
Global delivery team: A highly skilled team of 35 full-time employees (FTEs) from G&L’s UK, India, and US offices was assembled, providing around-the-clock coverage and timely deliveries.
Diverse expertise: The team’s experience, ranging from 2 to 20+ years, enabled G&L to handle various regulatory functions.
Global CMC support: Managing regulatory compliance for 35+ marketed products.
Post-approval variations/supplements: Handling 450-1,000 submissions annually.
License renewals: Supporting 50-100+ renewals annually across all markets.
Baseline dossier creation and gap analysis: Completing around 25 dossiers each year.
Emerging markets dossier authoring: Preparing over 50 submissions for emerging markets annually.
Health Authority responses: Managing queries and requests efficiently.
Submission planning and publishing: Comprehensive publishing services for Marketing Authorization Applications (MAAs), variations, renewals, Clinical Trial Applications (CTAs), and Clinical Study Reports (CSRs).

Impact and Outcomes

The engagement quickly demonstrated positive outcomes in several key areas:
Timeliness of submissions: Improved submission timelines across global markets were achieved.
Quality of deliverables: Enhanced dossier quality, leading to fewer regulatory authority queries.
Cost-efficiency: Efficiency gains enabled measurable cost savings, with the client seeing ROI as early as the cost-saving phase.