What I’ve learnt from preparing Regulatory Strategies – Now that you’ve started….

So now you really are ready to write that Regulatory Strategy or to present a verbal overview at your next meeting. If you missed my previous tips to help you be ready, refer to my previous article What I’ve learnt from preparing Regulatory Strategies… before you begin.

If you are lucky, you’ll have a clear scope to workshop. Though often your ask will be something broader like identifying the most attractive markets for a new product pipeline. Either way, you are expected to champion the organisational objective and craft a competitive Regulatory Strategy.  Balancing the seemingly conflicting needs of your organization with those of the Regulator (or multiple Regulators, as is often the case) requires both Regulatory prowess and alignment to your organisational drivers.

But how can you do this when faced with an initiative that seems just plain crazy? Try playing in the space of possibilities – for example, a June submission date might be achievable if the Clinical Study Report were to be available earlier. Remember also to differentiate between laws and guidances, and watch out for the objective behind the objective – for example, sometimes Regulatory approval is a more pertinent milestone than the Regulatory filing date.

Buzz words like options, risks, costs, and time have important roles in good Regulatory Strategies – use them. Quantify risk and benefit (e.g. in terms of cost, time etc) and capture key non-direct costs such as resource impact.  Consult your network, both internal and external – of course, without disclosing sensitive information to external contacts –  you may be surprised at the intelligence you gain.

It may sound counterintuitive but knowing when to stop researching is absolutely fundamental, there is usually opportunity to further to dissect your strategy following initial discussion. Keep your Regulatory strategy succinct, and leave details for appendices or verbal discussion.

Finally, organisational drivers and Regulatory trends do evolve, so don’t be afraid to revise your strategy.

Here are a few more tips for you …

Five questions to consider whilst preparing a Regulatory Strategy

  • What is in/out of scope?
  • How might Regulatory or organisational assumptions be explored?
  • What sources of Regulatory Intelligence might be helpful?
  • Who are the key stakeholders?
  • What Regulatory expertise might be helpful to engage?