Regulatory strategy and early health technology assessment

Service description

Covering pharmaceutical, ATMP, MDR legislation EATRIS provides regulatory support for most types of medical product. Our range of services include: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA;Pre-clinical and clinical plan development, Informal scientific advice with national competent authorities for highly complex projects, Access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

Sector

Biotechnology

Health and medical care

Technology Readiness Level

TRL 2 – Technology concept formulated

TRL 3 – Experimental proof of concept

TRL 4 – Technology validated in lab

TRL 5 – Technology validated in relevant environment

TRL 6 – Technology demonstrated in relevant environment

Financial requirements

Costs are charged according to the service, with regulatory expert fees ranging from €130 - €180 per hour. Fixed prices for specific services, such as ODD or Scientific Advice can be arranged so there is predictability of the costs.

Disclaimer related to service

We work with a braod network of experts across Europe, availability of specific competences cannot be guaranteed at all times.

Are you in doubt if this is the right service for you, or do you want to get more information about the service? Get in touch with the EIC Partner providing this service through this query form!

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Service

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Service ID

What is the challenge you want to overcome with this service?

In maximum 150 words. Please describe your needs focusing on the current challenges you are experiencing to advance your solution. This information is relevant for the EIC Partner to have a deeper understanding of your challenges and possible solutions.

How do you expect this service to help you address the needs and challenges you have identified?

Please include the deliverables you are aiming to achieve or seeking for.

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Please add any comments or suggestions tailored to your needs that you want the EIC Partner to take into consideration through this service.

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Please describe any questions or uncertainties you may have regarding the service description.

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At which Technology Readiness Level is your innovation or solution?

When filling out the justification, please describe the proof you have for the TRL.

Please give justification about the TRL

At which Business Readiness Level is your innovation or solution?

When filling out the justification, please describe the proof you have for the BRL.

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Do you have authority or ownership of your solution to disclose information to a third party, e.g., the EIC Partner?

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Why did you select this service?

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How much fund is needed to be raised

What is the funding needed for:

Please explain what are your actual financial needs and for what purpose you intend to use the funds raised?

Please describe your traction providing information on clients and sale.

Have you ever fundraised before?

Why do you need this strategy?

How do you want to develop the strategy: from scratch, rehash an existing strategy, etc.

Type of support needed

Type of support

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What is the ideal profile of the partner, investor or customer that you are looking for?

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Type of support (e.g., strategic, technical, financial)

Type of partners (type of organisations)

Sectoral domain of the partner

Purpose for the partnership

Please explain what are your needs for the team

Type of support (Business modelling)

Type of support (Business Plan development, go-to-market strategy, financial forecasts, softlanding programme)

Type of support (Market research)

Type of strategy (business planing, business modelling, marketing, sales, etc.)

Which is the target market?

Why do you need this strategy?

How do you want to develop the strategy: from scratch, rehash an existing strategy, etc.

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Why do you need this service?

I need to develop new business development strategies for my solution or startup

I want to get technical and skill support

I want to get information and knowledge

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Please specify the format you prefer (Online, in person, hybrid)

Type of strategy (business planing, business modelling, marketing, sales, etc.)

Briefly describe the areas in which you feel you need the most support in? (Try to be as specific as possible to help us with Coach and/or Mentor matching)

Briefly describe the areas in which you feel you need the most support in? (Try to be as specific as possible to help us with Mentor and/or Coach matching)

Which format and topic do you prefer to receive this service?

Group training, mentoring or coaching on a specific topic

1-1 training, mentoring or coaching on a specific topic

P2P

I am unsure of the best format for me and would like some guidance on coaching methods

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If in person or hybrid, please specify where you are able to access the facilities (Country)

Please specify the topic you are interested in

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What are your specific needs for your team in respect to coaching, training and mentoring?

Please explain if you are intending to incorporate a new team.

If other, please explain why you need this service:

Why do you need this service to access infrastructure and support R&D?

I need to get technical support for product or service development

I need to get access to technological or technical laboratories / equipment / testbeds

I need co-working spaces

I need access to R&D support funds and opportunities

I need access to technical expertise

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please specify which product or service you have

Please specify which equipment / tools you need

Please describe the type of trials, testing, experiments or other scientific activities you need to conduct

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If in person or hybrid, please specify where you are able to access the facilities (Country)

If other, please explain why you need this service:

Why do you need this IP & Legal service?

I need to get general information on IP or on regulatory aspects

I need to develop a strategy for my IP

I need to develop a strategy for regulatory compliance in a different market

I need to get information and guidance to apply protection for IP

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please describe the market you are targeting:

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What type of due diligence service are you looking for?

Investment readiness

Legal

Environmental

Technological

I need technical support for product or service valuation

I need information on how and where to conduct valuation

I need assessment of technology readiness or market readiness of my product / technology / service

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please specify which product or service you have and the expected results of your solution

If other, please specify what type of due diligence service you are looking for:

Why do you need this Prototyping & PoC service?

I need technical support for prototyping of product or service development

I need access to living labs or fablabs

I need access to expert guidance for prototyping

I need support in the Development of PoC

Support for validation of the prototype or PoC with end users

I am unsure of my specific needs right now and am looking for guidance on how to identify them

Other

Please specify which product or service:

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What type of service are you looking for?

For recruiting talent

For recruiting C-level professionals

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To access network or platforms to be used as sources of talent

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Human Resources

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Laboratory technicians

I need multiple functions

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Which are your target markets/countries for internationlisation?

Are you currently in the process of expanding or internationalising to foreign market or countries?

If yes, please name the market or country

What type of internationalisation support are you seeking?

Expansion and investment readiness assessment

Market Entry Strategy

Sales and marketing support

Fundrasing and commercialisation support

Distribution support

Matchmaking and networking support to meet foreign investors

Portfolio Oversight Support

Registration of company and/or joint ventures with foreign partners

Other

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