Ensuring regulatory success

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Meetings with Health Authorities such as the FDA in the US, the EMA in Europe or other major Health Authorities worldwide have shown to increase the probability of market approval and can have a most favorable impact on development times and costs. Since Health Authorities make the final decision to approve or reject products, it is highly recommended to optimize authority communication and to hold face-to-face and teleconference meetings all along the development pathway. But how do you get the best out of your meeting with a Health Authority?

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Authorities encourage to start discussions as early in the development process as possible so that developers can become aware of risks and weaknesses of their development plans to address them in a timely fashion. Meetings at critical milestones during development have been shown to dramatically increase the probability of timely approval.

Everyday Health has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).

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In the US, Everyday Health frequently engages with the FDA and has managed numerous of meetings with different FDA divisions for our clients (e.g. for pre-IND, End of Phase 2, pre-NDA or Type C meetings) or interacted with them in other drug development and authorization related procedures.

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Similarly, Everyday Health supports interactions with other major Health Authorities worldwide, facilitated by our local country-based affiliates and partners who can provide local procedural guidance and logistical support.