Innovative Drug European Associates

Keeping your EU submissions moving with our Regulatory-on-Call service

Despite having talented teams, small companies are forced to work with limited resources and access to specific expertise. They often lack the resources and experience in navigating specific regulations, the nuances of working in different countries and have limited time to spend on regulatory intelligence.

Working with a regulatory expert who is familiar with your product development and can provide on-call services or advice can make all the difference. Through our Regulatory-on-Call service, IDEA Regulatory offers a team of experts at the end of the phone or email, ready to answer any questions or carry out regulatory tasks.

Our Regulatory-on-Call service can supplement your existing team, allowing them to focus on managing and delivering your overall regulatory strategy. IDEA Regulatory’s experts know the relevant guidelines across all EU markets and stay on top of local developments. We can quickly answer questions about a process, regulation, guideline, or submission in the EU, or you can simply call our experts, who can point you in the right direction. With clinical trial uncertainty due to the coronavirus, if you need to make an urgent protocol amendment or a submission to temporarily halt a study, having an expert partner lined up at IDEA Regulatory means there’s always someone to guide you.

How does Regulatory-on-Call work?

You pre-purchase agreed hours of consultancy advice per month and IDEA Regulatory will have a team of qualified regulatory consultants who are familiar with your product and development plans available ‘on-call’ to answer your questions. The service includes:

  • A kick-off call to determine the potential types of advice and assistance needed
  • Familiarisation of our team of experts with your product and development plans
  • Assessment of the complexity of each query/task to determine the service needed
  • A flexible rolling balance of hours in credit allows you to roll-over unused time in to following months, or in more busy months, spend in advance from your future balance.
  • Regular reviews to ensure you are on the right plan

Whether it is supplementing your team or providing quick pieces of advice on-demand, IDEA Regulatory can support small businesses with stretched resources and small teams.

Contact IDEA Regulatory to learn more.

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