Regulatory dossiers write the story and connect the dots between your scientific data and target disease
PREPARE REGULATORY DOCUMENTS
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.
NETWORK OF EXPERTS
Ozack involves experienced subject matter experts to provide the best knowledge specific to your development program. We can set up a plug-in team with needed experts to evaluate your development program, identify GAPs and mitigation plans.
It is key that Ozack expertise is sharpened every day to be able to offer the best advice. Ozack is therefore a member of several organizations globally. - TOPRA (The Organisation for Professionals in Regulatory Affairs) - Dansk Biotek (Danish Biotech organisation) - DIA (Drug Information Association) - Danish LifeCycle Community - Board Assure Alumni