Designed for those seeking advice in either pharmaceutical or medical technologies. Provides the highest level of detail of all our advice processes.
- A
3 hour face-to-face meeting at NICE offices. - Detailed, stand-alone advice report with references and background information.
- Feedback on your development plan from a panel of experts including clinical, health economic, patient & HTA specialists.
- Optional clarification phase after receiving advice.
I truly value this Scientific Advice service provided by NICE. It creates fantastic opportunities for global drug development teams to better understand reimbursement hurdles and evidence requirements for timely market access. Great job!
Project feedback questionnaire
Briefing book submission
The briefing book provides us with all the important information about your project. It should include details such as the product's background, evidence to date and any proposed trials.
Depending on whether you wish to seek advice on a pharmaceutical or a medical technology, we have different requirements for the briefing book submission.
Download the briefing book template for:
Read the briefing book guidance for:
The process
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First contact
You contact us to discuss your requirements. You answer a series of preliminary questions about your product. We agree a timeline and send you our standard contract.
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You sign and return the contract
This must happen before the agreed submission date for the draft briefing book.
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Send us your draft briefing book
This is the key document that the project is centred around. A briefing book template for pharmaceutical companies is available for you to use.
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We send you a quote
Based on the content of your draft briefing book, we send you an initial quote for the project. You then have an opportunity to make any changes to your final briefing book before submitting the final version.
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wk1
Submit your final briefing book
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We confirm the project fee
Once we've reviewed the final briefing book, we confirm the fee. This may differ from the initial quote, if any changes were made.
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We send you an updated contract
We update the contract with the confirmed project fee and send you a copy for your records.
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wk6
We may ask some clarification questions about your product development plans
Having identified and spoken to our panel of experts, we may ask you to clarify or provide further information on certain details in your briefing book.
You'll have approximately 2 weeks to respond.
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wk10
Meeting with NICE and a panel of experts
Your team visits the NICE offices in either Manchester or London for a
3 hour face-to-face meeting. This is an exploratory open discussion of the key issues we've identified in your briefing book and helps us formulate our answers for the final advice report. -
wk18
We send our advice report
This is a detailed report with background, relevant case history and a comprehensive written response to each question posed in your briefing book.
Please allow a further 2 weeks if your project is classified as large.
Clarification stage (optional)
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+3 wks
You can send us any clarification questions you have about the report
These questions are to clarify the meaning of the advice and cannot
be requests for new information.Further follow-up advice can be arranged for an additional fee. Please contact us to discuss any requirements.
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+7 wks
We respond to your clarification questions, in writing