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.

01

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.

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What 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.

02

AI Integration & Change Management

AI Adoption · Process Digitisation · Regulated Environments

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.

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What 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.

03

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.

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What 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.

04

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.

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What 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.

Working together

Three ways to work together.

Most clients start with a diagnosis and decide afterwards whether to go further. Every step is a standalone engagement with a clear result and no follow-on commitment.

01

Diagnosis

A clearly scoped assessment with a written result and prioritised recommendations. The usual starting point.

Duration

1–3 weeks

Examples

  • —ISO 13485 gap analysis
  • —AI readiness assessment
  • —Workshop design and facilitation

From

€2,400

Fixed fee, depending on scope

02

Project

A defined build-out with clear milestones. I implement together with your team, not just on paper.

Duration

2–6 months

Examples

  • —QMS build-out to ISO 13485
  • —GenTSV §28 project management
  • —AI rollout and team enablement

Fixed fee

after scoping

Billed by milestone

03

Embedded / Interim

I work inside your team for a defined period, take on a role, and carry accountability.

Duration

3–18 months

Examples

  • —Fractional R&D leadership
  • —Interim project direction
  • —Cover during a recruitment search

From

€3,400 / month

1 day per week, minimum 3 months

  • All prices are net, plus statutory VAT. Offers are for businesses only.
  • Fixed fees apply to a defined scope and are billed by milestone. Embedded mandates are billed as a monthly allotment of days.
  • Travel within Germany is billed at cost or as a flat fee.
  • Reduced terms for pre-seed and seed startups and academic spin-offs on request.

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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