Overview

A large biopharmaceutical company expanding into the global biosimilars market required integrated and collaborative Regulatory Affairs assistance across multiple levels to guide the development and regulatory approval of its new portfolio.

G&L Healthcare Advisors provided expert support in both Chemistry, Manufacturing, and Controls (CMC) and clinical Regulatory Affairs, helping the client successfully navigate the complexities of biosimilar development.

Challenges

The biopharmaceutical company faced the following challenges during its biosimilar development journey:
Global regulatory compliance: The client needed support in authoring Common Technical Document (CTD) sections, navigating diverse global regulatory requirements, and preparing for Health Authority interactions.
CMC and clinical affairs integration: Collaboration across internal teams and with Regulatory Affairs was critical to ensure the seamless integration of clinical and manufacturing data.
Long-term and scalable support: As the project progressed, the client required scalable solutions to meet the demands of multiple biosimilar license applications across various markets.

G&L’s Approach and Solution

G&L assembled a team of highly skilled Regulatory Affairs professionals specializing in biologics and biosimilars to work directly with the client. This approach included:
Collaborative team integration: G&L embedded a team of Regulatory Affairs experts within the client’s existing systems and processes, ensuring that all deliverables were aligned with the client’s internal standards. By collaborating with internal teams across non-regulatory departments, G&L was able to streamline the CMC and Clinical Affairs processes.
Global regulatory submission support: G&L supported the global roll-out of the client’s biosimilars license applications by authoring critical CTD sections, contributing to the overall regulatory strategy, and managing communications with Health Authorities to ensure compliance and timely submissions.
Immersive and collegial environment: Working within an immersive and collegial environment, G&L’s team adopted the client’s core values and maintained a ‘can-do’ attitude throughout the project. This culture of collaboration helped the team tackle tasks of varying complexity, from day-to-day operations to larger strategic initiatives.
Scalable solution with train-the-trainer model: As the project scaled, G&L implemented a ‘train-the-trainer model', rapidly onboarding new consultants as needed. This allowed for quick knowledge transfer and ensured that each team member was highly productive from the start, providing the client with agile and flexible support.

Impact and outcomes

Through G&L’s seamless integration into the client’s team and strategic support across CMC and Clinical Regulatory Affairs, several key outcomes were achieved:
Long-term partnership and trust: G&L’s experts have supported the client for several years, contributing to the long-term success of their biosimilars portfolio. This enduring partnership has been built on trust, flexibility, and a commitment to customer-centric service.
Enhanced knowledge and expertise: Over time, G&L’s consultants developed deep expertise in the biosimilar landscape, allowing them to continuously add value to the client’s projects. This knowledge helped streamline processes and provided more effective regulatory strategies.
Scalable and flexible support model: As the client’s needs evolved, G&L quickly adapted to provide additional resources through the ‘train-the-trainer model'. This scalable solution allowed the client to handle increased workloads and expand their global biosimilars operations efficiently.
Successful regulatory submissions: The client’s biosimilars license applications were submitted successfully in multiple global markets, with G&L supporting Health Authority interactions, preparing CTD sections, and guiding the overall regulatory strategy.