Establish regulatory strategy to identify regulatory pathways, mitigate risks, and ensure you are on the right track
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.
Precedence: Ozack can extract and interpret publicly available regulatory documentation for product in development and in the market. Precedence is important to consider when establishing a regulatory pathway, incorporating important learnings from the regulatory Agency communication. Regulatory guidance: Ozack helps you apply the available guidance to your drug development project, to address essential topics. Regulations and directives: The regulatory environment of regulations and directives sets the framework for the regulatory area. Ozack will make sure you comply.
We engage with your project by digesting the available data and putting them into context of your next step in the development, whether it is your first clinical trial, or marketing authorization application. If you are planning a First in Human trial, Ozack can advise on the adequacy of your nonclinical package prior to clinical trial application. Moreover, involvement of national regulatory authorities is key for successful resolution of gaps in the development plan, where we can take the lead.
TOPICS FOR AGENCY INTERACTIONS
Ozack will recommend key topics to be discuss with the Agencies, based on the GAP analysis, regulatory intelligence and next steps in drug development. It is important that the number of uncertainties in your program is minimized. Scientific Advice is an excellent tool to do so.