Overview

A top 10 multinational pharmaceutical company sought to expand its presence in 70+ international markets but had limited local presence or knowledge of the specific regulatory requirements in these regions. 

G&L Healthcare Advisors was engaged to support the ompany’s central regulatory and Chemistry, Manufacturing and Control (CMC) teams and provide comprehensive regulatory intelligence, as well as develop a structured database to support the client’s global regulatory strategy.

Challenges

The client faced several key challenges in their journey to achieving its international regulatory objectives:
Limited market knowledge: The client had little to no local presence in many target markets and lacked real-life, on-the-ground insights into the regulatory processes.
Fragmented regulatory information: The central regulatory and CMC teams did not have a single source of truth for regulatory requirements across multiple countries, creating inefficiencies and inconsistencies.
Diverse global markets: The client needed detailed intelligence for over 70 markets, each with unique regulatory changes and challenges, making it difficult to establish a unified strategy.

G&L’s Approach and Solution

G&L provided a customized solution to meet the client’s global regulatory intelligence needs, leveraging its extensive network of local experts to deliver real-world regulatory insights across diverse markets. Key activities included:
Bespoke questionnaire development: G&L developed a tailored questionnaire designed to gather detailed regulatory information and timelines specific to each of the 70+ target markets. This questionnaire was distributed to G&L’s global network of consultants, ensuring that both regulatory guidelines and real-life experiences were captured.
Real-life regulatory intelligence: In addition to providing the official regulatory guidelines, G&L gathered practical, real-world intelligence from local consultants who had direct experience navigating the regulatory processes in each market.
Creation of regulatory database: G&L developed a regulatory requirements database in Microsoft Access, organizing the gathered intelligence into a user-friendly, centralized resource for the client’s regulatory and CMC teams. This database provided a comprehensive, real-time view of all regulatory requirements, changes, and timelines across the target markets.
Single point of contact: G&L assigned a dedicated project manager to serve as the client’s single point of contact, streamlining communication and ensuring the seamless coordination of regulatory intelligence from the network of local consultants.

Impacts and Outcomes

G&L's comprehensive support provided the client with an authoritative and actionable source of global regulatory intelligence, creating strategic advantages across multiple fronts:
Authoritative source of regulatory intelligence: G&L delivered a single, comprehensive source of regulatory information covering over 70 international markets, significantly improving the client’s ability to plan and execute global regulatory strategies.
Nuanced approach to regulatory insights: The client gained not only official guidelines but also real-life experiences from local consultants, offering a more nuanced understanding of how to navigate regulatory landscapes in each market.
Holistic view for central teams: The client’s central regulatory and CMC teams were empowered with a consolidated view of global regulatory requirements and timelines, allowing for more strategic decision-making and improved regulatory planning.
Enhanced global strategy: With G&L’s support, the client significantly improved its ability to plan regulatory changes and implement a cohesive global regulatory strategy across diverse markets.