Regulatory maze pathways & global strategy

Ozack will evaluate the regulatory options for your kind of product with the end in mind being your target indication and label. There are many ways to get there and we will explain pros and cons of the different options to guide you to the best pathway. The options and tactics will be described in a global regulatory strategy addressing priority markets and include a risk assessment of regulatory success. It is okay to take risks – we will make sure you know who they are before choosing a pathway. The regulatory strategy is a tool to describe possible development plans.

GAP analysis

We typically start by engaging with your project through digesting the data you already may have and put them into context of what your next step in development is. You may for instance have some preclinical data and assumed plans towards a First in Man trial. Ozack can advice if the nonclinical package may be adequate to get approval to start the clinical trial intended. We also advice if a discussion with regulatory agencies may be a good move to increase the chances of getting the clinical trial approved. GAPs can also be identified for an intended submission of a MAA or NDA/BLA.

Precedence within therapeutic area and technology

Competitor products overview

Today it is public on Agencies websites what the background for approval of product was. This precedence is important to consider when suggesting a regulatory pathway as it is possible to see how competitor products achieved regulatory approvals and what the challenges was from the Agencies.

Intelligence to apply

Regulatory guidances

It is important to know of any available relevant guidances/guidelines for the product being developed. The guidances show the topics that regulatory agencies expect addressed in the development plans. This does not mean they have to be followed precisely as they are written. It is important however that all is addressed and either followed or that there are good reasons to justify a deviation from the guidance.

Regulations and directives

The regulatory environment of regulations and directives set the frame for the regulatory area. Ozack will make sure you know of the ones that may be most relevant for your plans.

Recommend topics for Agency interactions

Based on the GAP analysis and the desired next steps in drug development Ozack will recommend topics where it may increase chances of success if they are sanity checked with Agencies in time. It is important that the number of surprises are minimized and an excellent tool to do so is to engage with the regulatory authorities from early development onwards.

Prepare regulatory documents

TPP, IB, CTA, IND, ODD, Fast Track etc.

Communication is an art – also in writing! At every interaction with Agencies documents need to be written as a background for the interaction and approval. The story must be described loud and clear from high level to an easy maneuvering into the details where the Agencies may see fit.
The TPP (Target Product Profile) is an internal document and extracts from this may be shared with Agencies to explain the objective with the development plan. Other dossiers are for submission such as CTA (Clinical Trial Application), IND (Investigational Ned Drug Application), ODD (Orphan Drug Designation), and Fast Track status. Ozack can prepare them all.

Ozack ApS
Ole Maaløes Vej 3
2200 Copenhagen N
Mail: ack@ozack.dk
Phone: +45 25 40 30 00