Since the global regulatory strategy combines regulatory requirements and business objectives, it cannot exist without the data.
Whether the health authority is the FDA, MHRA, EMA or SFDA, for example, the deliverable must be data-driven, and where the data do not exist, sound rationale must. To further complicate matters, the regulatory requirements evolve alongside advancements in medicine and treatment landscapes which impact regulatory decision-making, especially in the context of a major filing.
When it comes to a regulatory application, whether it is an IND, BLA, NDA or MAA, it is critical that the technical data package not only withstands the rigor of health authority scrutiny but is also of the highest quality in its presentation.
Typically, after End-of-Phase 2, the filing strategy is pushed to the forefront of a multidisciplinary team conversation. This is where your regulatory strategist will begin to partner with each functional area representative and associated SMEs/KOLs to construct the application framework specific to their area of expertise.
This process identifies strengths and weakness in the data, which serves to catalog possible filing deficiencies that may need to be addressed during the Agency’s review cycle, or which may be reason enough to possibly delay the filing – which is not ideal, but at times necessary.
We do not believe that the application should be written at the last minute, but rather as each phase of development is completed. When non-clinical evaluations/studies have been finished, our experts are constructing the data-narrative and finalizing study reports so that the application is literally being built in parallel with written analyses.
Success through experience
At G&L, we have been involved in hundreds of filings.
Drawing from this experience, we have refined the blueprint for each application type (as listed below). Our metric for success is not just gaining the regulatory approval, but also includes minimizing the number of information requests or deficiencies that the sponsor receives from the health authority.
As such, our work doesn’t end when the application is filed. Rather, we are intimately involved until a regulatory decision – an action letter – is reached.
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