Early venture partnership
Strategy simplified.
Impact amplified.
Early ventures often operate on lean organizational structure, tight timelines, and conflict between investor goals and controlling body priorities. Adding dedicated regulatory and quality support reduces long-term costs associated with re-works and milestone delays.
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S&D Consulting offers flexible support modalities including:
Serving as standby regulatory partner for startup accelerators and technology transfer offices
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Providing consistent direct support to startups, spinouts, and laboratories through flexible dedicated contracts
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Providing interim regulatory/quality assurance leadership to scaling companies to minimize business disruptions during hiring gaps
Who benefits?
Technology transfer offices
University-based startups face unique challenges that can result in fatal delays to productization:
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Lack of GxP infrastructure in academic labs
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​Grants from NIH, NSF, EU Horizon, etc. may prioritize scientific merit over demonstration of commercialization potential, leading to misalignment of project design with study structure requirements such as compliant DHF, design controls, or technical files
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Underdeveloped supplier qualification and risk management infrastructure
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S&D Consulting has experience working directly with grant-funded academic labs and can serve TTOs as a regulatory affairs partner on standby. This allows spinouts to get the hands-on support they need on demand through flexible contracts, preventing delays associated with ad hoc external consultantships and de-risking from the ground up.
Startup Accelerators/Incubators
With many startups of different stages, sizes, and product types, accelerators are often limited in their ability to connect fast-moving businesses with dedicated regulatory support when they need it. ​​​​
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Nominating a regulatory and quality assurance partner provides your diverse and dynamic startup portfolio with flexible, fractional solutions that keeps startups compliant without the burden of full-time overhead
Academic spinouts and translational research initiatives
Projects led by university-based PIs offer superior innovation potential but often suffer from a lack of compliance-ready infrastructure and conflicting priorities:
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Projects funded by SBIR and STTR grants may defer regulatory planning due to lean organizational structure, risking delays and reworks during critical Phase II/III transitions
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Misalignment between regulatory requirements and the goals of multiple investors and funding bodies, shared IP ownership, and pressure from universities to priorities publication over commercialization can result in deficient study design and
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Funding proposals often do not take into account realistic timelines for submissions to regulatory agencies, resulting in missed milestones
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Lean organizational structure and lack of exposure to commercialization-focused study design can hinder researcher-led ventures
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S&D Consulting has hands-on experience with both selection and support of projects under translational research initiatives, and can provide pre-award strategy development, post-award study design support, and scalable QMS and regulatory compliance planning.
Venture Capital-backed startups
Entrepreneur-led startups grow quickly and often hold the advantage in terms of business development, but still face risks associated with disconnection between research and business leadership:
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Investors may lack understanding of the technical underpinnings of innovative projects and their development context, resulting in difficulties securing additional funding and agreeing upon timelines​
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Investor goals may misalign with regulatory requirements, especially for novel technologies that lack defined regulatory pathways
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S&D Consulting can help facilitate productive communication between scientific and both internal and external business leadership, help integrate risk management into dynamic business models, and accelerate the approval process by applying decades of experience with regulatory leadership.