ILAP Submissions

The UK’s Innovative Licensing and Access Pathway

An early adopter of the Innovative Licensing and Access Pathway (ILAP), Niche Science & Technology Ltd was the first CRO to submit a successful ILAP application. We have the experience and understanding of the ILAP pathway to guide you in your submissions to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

A FastTrack to establishing communications between innovators and regulators, ILAP represents an opportunity open to commercial and academic organisations, offering support in the delivery of new and repurposed treatments. The initiative provides a safe, timely and efficient route for the development of medicines. We can support you at any stage in the submission pathway:

1. Development of your ILAP application, submission and preparation of your summary MHRA presentation/meeting minutes
2. Preparation of your Target Development Profile (TDP)/Roadmap
3. Coordination of your access to the enhanced regulatory and stakeholder toolkit to guide future decision making, trial design and key development strategies

Our services are tailored to your needs, beyond the initial ILAP engagement we can also provide support in terms of:

• Development of managed promotional campaigns, strategic communications plan and support with press releases
• Clinical and scientific/feasibility review
• Full project management to facilitate writing and meeting requirements
• Production of any regulatory documentation to support ILAP approval or following MHRA requirements.

For more information on our ILAP success story, read this news story: http://www.fyi-news.co.uk/rational-vaccines-wins-mhra-ilap-passport