International Biotech MA project

Initial MA Application

• Defining regulatory Strategies (legal basis, health authority meetings)
• Supporting the client with creation of dossier to ensure all local requirements are included. We intervene in questions related to the Local Dossier and provide advice on the way to address these questions
• Management and preparation of local/National documents

In each country

• PLG share the REG Intelligence with the client so that they can decide whether to go ahead or not with the project
• Defines RA strategy and associated timelines for each submission
• Defines the content of the dossiers and prepares the submissions

Operations

• Defines Regional/Country Submission Teams with some local expertise
• Prioritize and allocate resources
• Endorse proposed timelines
• Monitor progress
• Point of escalation for Regional/Country Submission Teams
• Monitor project budget
• Maintains effective communications among the project team and Senior Management

• Successful project methodology which is then adapted to the client’s internal processes and objectives; and a project roadmap (strategy & planning) adapted to client’s objectives and regulations
• Gather a dedicated team to support the client with the initial filing of the Biotech product
• Commit to submissions deadlines
• Source & make use of local experts to define regulatory strategy
  and plan submission as soon as possible
• Develop specific processes to manage and monitor the progress
  of the activities
• Communicate better, track and trace the project roll out
• Be able to reuse the project methodology & Regulatory Intelligence information in other projects (for this Customer or for other customers)

In the rising domain of Biotechnology, a monoclonal antibody / biomolecule product has already been approved in some markets and is in progress to be rolled out with PLG’s support in 17 more. Customer’s objective for PLG is to gain marketing application approval on those 17 markets.

This product and its go-to-market success being strategic, Customer’s team covers its whole organization: CMC, Clinical, Clinical pharmacology, Safety, Non-clinical, Pharmacology, and of course also Regulatory Strategy & Business Operations, Commercial, Marketing, …

The investment of the Customer is important and needed to rely on a trustful partner for supporting its initial marketing authorizations (MA). The customer wanted to have a separate team from the normal maintenance team.