Services
Built for organisations that do real work.
Every engagement is embedded. That means I work inside your team, carry accountability, and measure success by what your organisation can do after.
Regulatory Affairs
GenTSV · ISO 13485
Regulatory frameworks are not obstacles. They are architecture. Built right from the start, they become a competitive advantage rather than a bottleneck.
View detailsWhat I deliver
- —GenTSV §28 project management and biosafety documentation
- —ISO 13485 QMS build-out, internal audits, and gap analysis
- —Regulatory strategy for biotech and diagnostic startups
- —Risk assessment frameworks and documentation
- —Audit preparation and regulatory authority communication
Who it's for
Early-stage biotech companies, diagnostic startups, and life science SMEs entering regulated markets.
SME Transformation
AI Integration · Process Digitisation · Change Management
AI is not a technology problem. It is an organisational one. I work with your team to identify where automation creates real value — and where it does not.
View detailsWhat I deliver
- —AI readiness assessment and opportunity mapping
- —Process digitisation and workflow automation
- —Change management and team enablement
- —Build-vs-buy decision frameworks for digital tools
- —Implementation roadmap with prioritised milestones
Who it's for
Industrial and life science SMEs navigating digitisation, automation, and AI adoption.
Team & Organisational Development
Leadership · Structures · Capability Building
The fastest way to fail a transformation is to underinvest in the people who have to carry it. I build the organisational capacity that makes change stick.
View detailsWhat I deliver
- —Team structure design for R&D and cross-functional environments
- —Leadership development for scientist-founders and technical managers
- —Workshop design and facilitation
- —Organisational diagnosis and recommendations
- —Onboarding and knowledge transfer systems
Who it's for
Founder-led companies scaling their teams, and established SMEs repositioning for the next phase.
Interim Management
Embedded Scientist · Fractional R&D Lead · Project Director
Sometimes you need experienced scientific or operational leadership for a defined period without a permanent hire. I take on the role, carry full accountability, and build the foundation for whoever comes next.
View detailsWhat I deliver
- —Fractional R&D leadership for early-stage companies
- —Lab build-out, process development, and team formation
- —Project direction for defined transformation programmes
- —Transition planning and successor enablement
- —Full documentation of processes and decisions
Who it's for
Startups between hires, companies scaling faster than their org chart, and programmes that need senior accountability.
Not sure which service fits your situation?
Most engagements start with a conversation, not a predefined scope. Tell me where you stand, and I will figure out what fits.
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