Together we make change that matters
Regulatory consultancy that helps you
Work with Ozack
Engaging in drug development means entering a highly regulated area with countless options and hidden pitfalls.
Ozack can help you ensure value is created at every step.
We also have extensive experience and an established network of subject matter experts ready to step in when needed.
Advice to Communicate
Regulatory Strategy to Navigate
50+ development projects
antibodies, small molecules, biologics, vaccines, drug-device combinations, ATMPs
Ozack will evaluate the regulatory options for your type of product with the end in mind, including the milestones on the way towards your labelled target indication. The options and tactics will be described in a global regulatory strategy. It will address priority markets and include a risk assessment of regulatory success. We will explain pros and cons of the different options to guide you to the best path. It is okay to take risks – we will make sure you know what they are before choosing a pathway.
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 dossiers.
Regulatory strategy reveals the topics and timing of any Agency Advice. For each Advice, Ozack will establish the framework, and you guide towards the most optimal outcome.
'Flexibility and commitment combined with experience and professionalism was how Ann Christine ensured that our project was regulatory compliant and completed on time'
CEO, RhoVac AB