Ozack can help you connect the dots and to efficiently communicate your science to the regulators. Your story must be consistently told across disciplines which are compiled into a submission dossier. This is applicable whether you aim to have an: - Agency interaction (pre-CTA, pre-IND, Scientific Advice, End of Phase II, pre-NDA, pre-MAA, SME Meeting, PDCO) - Pediatric Plan (PIP, PSP, PPSR) - Clinical Trial Application (CTA, IND) - Designation (Orphan Drug, Fast Track, PRIME, ATMP, Breakthrough, CAT, …) - Marketing Authorization (MAA, NDA, BLA) We can help you prepare and time all these submissions to the benefit of your development program.