A Blueprint For Innovation
Upstart Bio is dedicated to advancing early-stage technical organisations, projects and scientific initiatives within the fields of life science, molecular biology, and diagnostics. Our objective is to assist in establishing strong foundations and guide progression from initial concepts to successful commercial outcomes.
Balancing The Challenges Of Starting A Business With The Need To Maintain Technical Momentum, Scientific Rigor And Regulatory Compliance
Life Science start-up organisations and entrepreneurs have to be able to multitask and quickly learn new skills. Taking on new roles as fundraisers, directors and administrators whilst still addressing the challenges of innovative product development can be a difficult balance, especially on limited resources.
Frameworks for Innovation
We aim to deliver expert professional services by integrating scientific knowledge with industry experience, providing tailored, practical solutions for each client’s specific challenges and stage of development. Our support enables innovators to optimise processes, advance proof-of-concepts, and reach key investment, funding, or regulatory milestones. Whether your organisation requires guidance on technology development, implementation of best practices, establishment of technical facilities, due diligence, grant-funding applications, or operational workflow development, Upstart Bio is dedicated to realising your goals, driving success, and laying solid foundations for future growth.
Product Development
Upstart Bio has a strong background in innovative product development in life science sectors, managing projects from concept to launch in alignment with business and regulatory objectives.
Requirements Management
Clear technical requirements are key to building successful products. Upstart Bio helps teams turn market data into actionable specifications by promoting effective collaboration and communication.
Process Scale-Up
Upstart Bio will bring focus to effective scale-up strategies and forward planning to reduce project scale-up risks.
Research & Development Leadership
Pragmatic, hands-on, experienced leadership. Enabling organisations to manage critical business resources confidently and effectively.
Grant Application Support
Helping businesses apply for funding or manage grant funded projects efficiently
Establishment & Growth Of Technical Facilities
Helping start-ups work with existing facilities and focussing on what's needed to meet key milestones
What Our Clients Say
About Upstart Bio
Our aim is to provide the foundations for commercial success and provide practical support for new and growing businesses
Ready To Get Started? Start Here.
Have Questions?
Can you support IVD (in vitro diagnostic) device projects?
Yes, this is the mainstay of our work, and we have extensive experience working with nucleic acid (DNA and RNA) purification, PCR, NGS/ sequencing, infectious disease diagnostics, cancer diagnostics, and lab automation/ instrumentation.
Can you support Medical Device projects?
Yes, especially if they are in vitro diagnostic devices, but for other types of medical device there is significant overlap of the regulations so many of the principles are transferable. Please enquire to find out if we can help.
Can you support software-based projects?
Yes, many diagnostic products now involve software, either for driving instrumentation or as standalone products (software as a medical device, or SaMD). Please enquire to find out if we can help.
Can you support projects involving medicinal products?
No, this typically involves different processes and not within our scope of expertise.
Do you carry out contract research?
No, but we can provide remote and on-site support for your organisation and can run or monitor projects that involve subcontractors or collaborating organisations (Contract Research Organisation/ CRO’s, CDMO’s), but we do not have the facilities to carry out contract research.
Do you carry out clinical research?
No, this is not within the scope of our expertise, but we can provide remote and on-site support for your organisation and can run or monitor projects that involve subcontractors or collaborating organisations (Clinical Research Organisation/ CRO).
Are you Regulatory or Quality Management Consultants?
No, not strictly speaking, but we have extensive experience of setting up systems and developing products and systems that aim to comply international standards (ISO 9001, ISO 13485, ISO 14971, IEC 62304) and regulatory frameworks (UKCA, CE, FDA). We also provide pragmatic advice that fits your organisation and stage of growth, with an eye on the future ensuring that these avenues are always available should your innovation go down that path.
Do you carry out internal audits?
No, not for QMS or regulatory purposes, but we can assess and provide alternative viewpoints on your approach to project management or design requirements management.
Do you undertake due diligence work?
Yes, we can assess project plans and provide alternative viewpoints on approaches to project management or design requirements management.
How much do services cost?
Each project is unique, so we can provide estimates based on a short discussion of your needs and the scope of work, or a virtual or face-to-face meeting. We can then provide an estimate based on a time commitment, or for the total cost of a project over a period, whatever works best for you.
What project management templates can you provide?
As part of any formal engagement, you will be free to use our project management resources including, Dashboards, Report Templates, Risk Management formats, various logs for event tracking (e.g. RAID logs, Rolling Action Lists, etc.). Also, you will have access to our Requirements Tracking Database (RTD©), which helps to maintain links between different types of requirements and the stages of product development and handles device risk management.
Do you write grant applications?
Yes, we can support your application process. You are the experts in your technology and markets, but we can help structure your application and make sure that you are including the most relevant information to help achieve success.
Do you undertake marketing projects or carry out market research?
Not directly, this is not within our scope of expertise, but due to the nature of our work, we have several contacts that could help and we would be happy to put you in touch. Please enquire to find out how we can help.
What other projects can you support?
We also have experience in microbial fermentation, microbial strain development, and some food product development projects (particularly if microbes are involved!).
