Services
Our services accross your entrepreurial journey
R & D
Design and development
Commercialization
STRATEGY
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Evaluation of business potential
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Market and competition analysis
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Clinical need assessment
INTELLECTUAL PROPERTY
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Freedom-to-operate analysis
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National Patent application
FUNDRAISING
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Fundraising Pitch
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Legal documents for investment round
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Public grants applications
STRATEGY
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Business modeling and
Value Proposition
REGULATORY CERTIFICATION
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Regulatory Roadmap
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Classification and Intended Purpose
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Risk assessment
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Clinical validation
INTELLECTUAL PROPERTY
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European, PCT Patent application
FUNDRAISING
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Fundraising Pitch
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Legal documents for investment round
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Public grants applications
STRATEGY
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Go-to-market strategy
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Sales strategy
REGULATORY CERTIFICATION
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Technical file for CE or FDA certification
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Quality management system
INTELLECTUAL PROPERTY
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Patent portfolio management
FUNDRAISING
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Fundraising Pitch
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Legal documents for
investment round -
Public grants applications
Regulatory roadmap and CE/FDA certification
We support clients in in-vitro diagnostic and medical device (including digital health) CE or FDA certification journey, from regulatory road-mapping, detailed outline of the necessary requirements and documentation, to tailored gap analysis. Moreover, we contribute directly by preparing and compiling the technical documentation and quality management system, all the way to liaising with accredited labs for necessary stress-tests and with appropriate notified bodies for submitting applications.
Get in touch for:
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Quality management according to ISO13485, 21CFR820
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Regulatory Affairs CAPA Classification according to the IVDR, MDR
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Technical Documentation according to the CE, 510(k), PMA
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Clinical, performance and biological evaluation according to MDR, IVDR, ISO10993, ISO14155, MDCG
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Risk management ISO14971
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Electrical safety IEC60601-1 IEC60601-1-2
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Software development processes IEC62304 IEC82304
We support clients in performing their market and competition analysis, identifying best business and revenue models and go-to-market strategies. Thanks to the complexity and specifics of the healthtech market, these elements are essential to consider upfront, in order to launch or scale a profitable business.
Get in touch for:
-Clinical need and market size analysis
-Competition analysis
-Business and revenue model identification
-Go-to-market strategy analysis
-Business plan design
MARKET AND
BUSINESS STRATEGY
FUNDRAISING
We provide hands-on support in preparing for various funding rounds. We advise on healthtech industry investors’ criteria and requirements, as well as on effective pitch preparation (content, design and convincing presentation techniques). Prior to finalization of the round, our legal experts provide individual support on legal documents’ analysis. We also facilitate the connection with our relevant international investors’ network and can arrange individual pitching opportunities directly to healthtech VCs and Business Angels.
Get in touch for:
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Pitch in healthtech: pitch content according to the international investors’ metrics in healthtech; pitch design, simulation of Investors’ meeting and convincing presentation techniques
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Legal investment documents: term sheet, shareholders’ agreement, Investor’s agreement tailored to your specific case
We can support you in identifying the most relevant European grant opportunities, in forming a consortia, in writing the application for the call and in the overall management of the grant application process and beyond. Importantly, in order to define the suitability of the candidate project to the related funding scheme and to explore the potential matching with the consortium, we offer Proposal Validation assessment free-of-charge.
Get in touch for:
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Identification and completion of the consortium
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Proposal preparation, writing and submission
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Support on budgeting
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Preparation for- and facilitation of the negotiations
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Support in meeting requirements and getting access to the Funding contract (the “Grant Agreement”)
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Management of the information on the Participant Portal and other.
PUBLIC GRANTS APPLICATIONS
DATA PROTECTION AND PRIVACY
We can help to navigate GDPR, privacy and data protection laws and regulations, perform gap analysis and advice on the best strategies to meet legal requirements. We also offer hands-on compliance support and directly work on the technical implementation of necessary systems ourselves so that the client can focus on running the business instead.
At 2AM Health we help various private and public organizations and industry stakeholders to design their skill-building and educational events within life science (LS) entrepreneurship and innovation areas. Through workshops, acceleration programs, masterclasses, seminars and webinars, we support various organizations and companies with full execution of the events: from idea to program creation, to the expert sourcing and to the moderation of the event and audience engagement.
Some of the recent 2AM Health events:
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Investors in life science- roundtable of international VCs and business angels with LS focus, February 2021. Client: Enterprise Lithuania
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Fundamentals of medical device certification, March 2021. Client: Agency for Science, Technology and Innovation (MITA), Lithuania
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Entering German market for life science companies, May 2021. Client: Enterprise Lithuania
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Achieving success in EU funding applications for LS, a hands-on training from one of the best performing European grant office - UCL London, July 2021. Client: MITA, Lithuania
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Startup Masterclasses and Pitch Battle in Life Science Baltics conference, September 2021. Client: Enterprise Lithuania.