Liaise with stakeholders and Health Authorities as partners to demonstrate credibility and trust in your project
We can perform regulatory assessment of a drug on your behalf, if you need to evaluate the regulatory potential of a licensing opportunity. Data has no value if it is not properly documented and well organized for someone to assess and take over. At the stage of Due Diligence, it is key to have things in order to maximize the value of the asset. This includes QA, document integrity and Good Documentation Practice. Ozack can pull in experts to organize your documentation to ensure it is easy to navigate.
Regulatory interactions are key inflection points of value for investors. Ozack will make sure the regulatory activities contribute optimally to your fundraising activities throughout your development program.
Regulatory strategy reveals the topics and timing of any Agency Advice. For each Advice, Ozack will establish the framework, and guide you towards the most optimal outcome. Ozack will take the lead in preparation of required briefing material for the Agencies, take you through the interaction and follow up on the advice received. Regulatory agencies are enablers rather than gate keepers, even though the route to patients leads through them. They encourage companies to approach them early to discuss their development plans and offer many ways of engagement.
Ozack provides clear communication on regulatory strategy and development plans, suitable to be presented to Board of Directors, and other stakeholders. We deliver project plans, with key milestones to demonstrate progress in your development. Ozack will use the project plans to ensure all contributors and deliverables are on track.