Liaise with Health Authorities as partners for the success of your product. This will demonstrate credibility and trust in your project.
When and how to ask
Rehearsal for meetings
The route to the patients goes through the regulatory agencies. They encourage companies to come early to discuss their development plans and offer many ways of engaging. Ozack will advise on topics to ask and the timing for when it may be strategically wise to do so. We will prepare the briefing material for the Agencies with you and lead you through the interaction as well as follow up on the advice received.
Success through accountability
Accountability individually and together at the same time is key to success in any situation. Ozack can train you and your teams on how to increase accountable behavior which means we all think “What else can I do to achieve the success we want?”.
Regulatory Affairs can seem complex for many. If it is used well then it facilitates development and Agencies can be used more as enablers than gate keepers. Ozack can train you and your teams in regulatory topics at every step of the regulatory path. We can also take your development plan and show in one page the regulatory opportunities for engaging regulators in your particular program.
Readiness for due diligence
Perform due diligence
Most development programs will go through Due Diligence at some point. At that stage it is key to have things in order to be able to describe the asset. This cover QA level and Good Documentation Practice. Data has no value if it is not properly documented and well organized for someone to assess and take over. Ozack can organize your documentation so that it easy to navigate for a company on coming for Due Diligence. We can also perform Due Diligence on your behalf if you need to evaluate the potential value of a licensing opportunity.
Risks and Mitigation Strategies
Communication tools for BoD meetings
Communication to Board of Directors has to be to the point and easy to see in a snapshot. Ozack has experience with tools that work well at this level. They can describe a development program high level and the regulatory actions that may create value at every milestone and mitigate risks in the plans.
Value inflection points through
You get no money if you can’t tell your story WELL. Most small biotech companies are very dependent on receiving investment on an ongoing basis and Ozack will make sure the regulatory activities contribute maximum to the value inflection points during development. Activities like meeting EMA or a national agency in Europe, getting approval to start a First in Man trial, or agree a meeting with FDA are examples that will add value.