An independent technical and market verdict, in weeks, from someone who has developed, filed and licensed products himself.
“Will this asset’s science, product, regulatory path and market survive scrutiny — and how realistic is the plan?”
Change Managed®from Insights to Action
Clarity before you commit. Delivery once you decide.
Due diligence, market intelligence and hands-on product delivery for medical devices, diagnostics and medicines — across Europe and China.
One connected offer
A catalogue of methods.
Insight you can trust, and the delivery to act on it.
Our diligence is sharper because we have built products. Our delivery is faster because we start from the facts.
One leaf, two halves
Insights | Change Managed® | Action
The ginkgo has two lobes joined by a single stem. Hover or tap a lobe to see the three service lines on each side.
Insights
Know before you commit
- 01Due diligence — investment, licensing, technology and supplier diligence; technical, CMC and regulatory red-flag reviews
- 02Market research & intelligence — competitive and supplier landscapes, customer needs, market-entry strategy for Europe and China
- 03Technical, regulatory & market-access assessment — capability and gap analysis, regulatory pathway, DPP readiness
Hover a lobe
Action
Deliver once you decide
- 04Development & portfolio governance — stage-gates, prioritisation, target product profiles, fractional Head of Development or PMO
- 05Regulatory, materials & impurity compliance — ICH M7, ICH Q3D, USP <665>, PFAS substitution, MDR transition, supplier qualification
- 06Product data, PLM/PIM & Digital Product Passport — DPP under ESPR, UDI, EUDAMED, electronic instructions for use
The stem · Change Managed®
How we turn insight into action: we establish the facts, align the people who must act on them, and see the change through.
Facts establishedPeople alignedChange seen through
Insight without action is a report on a shelf.
Action without insight is a risk.
Who we help
Five buyers. Five different questions.
Pick the one that sounds like you. Each has its own entry point, its own evidence and its own first step.
Senior development leadership when you need it, without the full-time hire.
“What does a credible development and regulatory path look like — and who can run it with us without a full-time executive hire?”
Your situation
Strong science, but no one who has taken a product through development governance, a dossier or a Notified Body. Investors are asking for a credible roadmap.What you see in 10 seconds
That we have built and run development organisations, and that we work in fixed, affordable packages.Your doubts, answered
Cost, and the fear of a consultant who writes a report and leaves. Entry: an investor-ready roadmap sprint. Follow-on: fractional leadership, fixed days per month.Evidence
Pfizer China function built in three months; target product profiles and development plans at Roche and Bayer.When your programme is stuck, we find out why — technically and organisationally — and get it to closure.
“Why is this not moving, and how do I get R&D, QA, procurement, suppliers and management aligned behind a decision?”
Your situation
Stalled nitrosamine or elemental impurity assessments, extractables and leachables under USP <665>, PFAS substitution, MDR transition backlog, supplier qualification, inspection findings that do not close.What you see in 10 seconds
That we understand your specific technical problem, in your own vocabulary, and have unblocked similar ones before.Your doubts, answered
“We already use a testing lab.” We decide what should be tested and how results land in the file; laboratories are partners.Evidence
Nitrosamine (ICH M7) and Q3D programmes at Fresenius Medical Care; CMC dossier revisions and EU procedures at Bayer; materials and supplier-qualification diligence for device components.From scattered product data to PLM, PIM and Digital Product Passport compliance — with the change management that makes new systems stick.
“What does compliance require of our product data, what is the business case — and how do we get our people to work in the new PLM and PIM processes?”
Your situation
Product data scattered across systems; a PLM or PIM implementation underway or stalled; regulations now require structured, traceable, digital product information (DPP, eIFU, UDI).What you see in 10 seconds
A clear explanation of the obligation and the business case, and proof of leading long-term data and PLM/PIM programmes — not a software sales pitch.Your doubts, answered
“Our PIM or PLM vendor already does this.” Vendors implement software; we make the organisation adopt it and keep the data compliant.Evidence
Long-term OEM engagements as change and project lead for data management, PLM and PIM; digital content delivery for a world-leading pump manufacturer with break-even in year one; PTC Windchill and design history file experience at Fresenius Medical Care.A fact base built for your decision, not a report bought off the shelf.
“What does the market, the supplier landscape or the regulatory environment really look like — or why are we not chosen as preferred vendor — and what should we do about it?”
Your situation
Preparing a market entry, a supplier selection, a material change, a partnership or an acquisition; you need an independent, structured and sourced fact base quickly.What you see in 10 seconds
Report quality: structure, sources, clarity of recommendations; sector depth in medical and regulated products.Your doubts, answered
“We can buy a syndicated report.” Every study is commissioned, scoped to your decision and ends in recommendations.Evidence
Recent reports (anonymised): medical-grade thermoplastics in disposable devices; supplier selection and qualification for injection-moulded dialysis components; diligence on a European healthcare operator.
Offer architecture
Two halves. Three service lines each. A defined first step for every one.
Retainers are rarely bought cold. So every service line starts with a scoped entry project — and has a natural follow-on.
Insights
Due diligence
Investment, licensing, technology and supplier due diligence; technical, CMC and regulatory red-flag reviews; China-origin asset diligence; BIOSECURE and supply-chain exposure.
Entry projectRed-flag or full diligence report, 2–4 weeks, verdict first
→
Follow-onDiligence desk: screening memos per quarter, priority turnaround, post-closing monitoring
Market research & intelligence
Market dynamics beyond surface sizing; competitive and supplier landscapes; customer needs; market-entry strategy for Europe and China.
Entry projectScoped market study with recommendations
→
Follow-onMarket and regulatory watch: periodic updates for your decision-makers
Technical, regulatory & market-access assessment
Capability and gap analysis; regulatory pathway; CMC readiness; materials and impurity risk screening; Digital Product Passport readiness.
Entry projectAssessment with roadmap, 4–6 weeks
→
Follow-onLeads into the matching Action service line
Action
Development & portfolio governance
Stage-gate governance, portfolio prioritisation, target product profiles and development plans; fractional Head of Development or PMO.
Entry projectInvestor-ready roadmap sprint
→
Follow-onFractional leadership, fixed days per month
Regulatory, materials & impurity compliance programmes
Programme leadership for nitrosamines (ICH M7), elemental impurities (ICH Q3D), extractables and leachables (USP <665>); PFAS substitution; MDR transition; supplier qualification.
Entry project4–6-week unblock diagnostic
→
Follow-onProgramme steward until closure: steering, governance, supplier and Notified Body interfaces
Product data, PLM/PIM & Digital Product Passport
Change management and project leadership for data management, PLM and PIM programmes at OEMs; DPP readiness and implementation under ESPR; digital content delivery; UDI, EUDAMED and electronic instructions for use.
Entry projectReadiness assessment with business case
→
Follow-onLong-term programme or change lead for PLM/PIM implementation; regulatory horizon watch
Engagement formats
ReportAssessmentProgrammeFractional leadershipRetainer
Every engagement is led personally by the founder, supported by vetted functional experts and partners.
The client journey
Assess. Decide. Deliver.
A path from the left lobe, through the stem, to the right lobe. Insights is the front door — and every Action service is grounded in an assessment.
01
Assess
“What is really going on?”
Due diligence, market study or technical assessment — sourced, structured, verdict first.
● Left lobe · Insights02
Decide
“What should we do, and who must be on board?”
Options, recommendation and stakeholder alignment — Change Managed®.
● Stem · Change Managed®03
Deliver
“How do we make it happen?”
Programme, fractional leadership or implementation oversight to closure.
● Right lobe · Action
After the report
Plan the next step
What happens after the report?
Every Insights engagement ends with a clear next step. You can stop at the verdict — or carry it into delivery with the same person who wrote it.
Why now
Six developments your board is already asking about.
Each trigger has an Insights answer and an Action answer. Swipe through.
US$0bnChina innovative-drug out-licensing, Jan–Jun 2026 — a record [1]
China out-licensing boom
Average upfront payments rose about 230% between 2022 and 2026 [2].
Affects: investors; Chinese start-ups seeking partners
Due diligence→Global-readiness assessment
Dec
2026
2026
BIOSECURE Act
Signed into US law in December 2025; the list of biotechnology companies of concern is due by December 2026, with prohibitions possibly effective from 2027 [3].
Affects: investors; companies with China supply chains
Due diligence→Supply-chain exposure
1 May
2026
2026
USP <665>
The chapter on plastic components used in drug manufacturing became official on 1 May 2026 [4].
Affects: quality and regulatory heads in biopharma
Assessment→Compliance programme
Open
EU PFAS restriction
Medical devices are assessed separately, but no specific exemption has been confirmed yet [5].
Affects: med-tech quality, R&D and procurement
Materials assessment→Substitution programme
2027
EU MDR / IVDR revision
Revised regulations are targeted for adoption in 2027; current rules still apply meanwhile [6].
Affects: med-tech start-ups and quality heads
Regulatory assessment→Transition support
Feb
2027
2027
Digital Product Passport (ESPR)
Obligations arrive product group by product group; the first mandatory passports (batteries) apply from February 2027 [7], with further groups in the 2025–2030 Working Plan [8].
Affects: industrial manufacturers; exporters from China to the EU
Readiness assessment→Implementation
Market and regulatory status as of October 2026. Figures to be re-checked at publication.
Proof, not adjectives
Assessments from someone who has brought regulated products to market.
0 yrs
Regulated products
Across the full value chain — from medicinal chemistry to portfolio, regulatory and engineering leadership.
Kerendia®
Drug discovery
Contributed to the lead optimisation of finerenone at Bayer; co-author of the 2012 discovery publication; co-inventor on numerous patent applications.
About · investors · start-ups0
EU member states
Steered an EU Mutual Recognition Procedure across 16 member states, incl. negotiations with the Paul-Ehrlich-Institut on biologics; revised CTD Module 3 documentation.
0 months
Pfizer China
Built Pfizer China’s portfolio and project management department in three months, covering 38 assets and 69 projects.
0
Portfolio leadership
Managed a global portfolio of 96 pharmaceutical and medical device projects (2021); team engagement up 32% over two years.
€0m+
Lifecycle
Led global project teams at Bayer adding six projects to the pipeline; brand-defence project protecting over €50 million in sales.
US$0m
China turnaround
Led a cross-functional assessment and change plan to restructure a diagnostics company’s China business towards a US$200 million sales target.
0+ yrs
Lived & worked in China
Dr. rer. nat. in Chemistry (summa cum laude), TU Dortmund; postdoc, University of Glasgow; more than 15 peer-reviewed publications; PMP®.
Career historyBayer · Roche · Pfizer China · UCB Pharma · Fresenius Medical Care · TU Dortmund · University of Glasgow
Illustrative layout · anonymised
Prometheus InnoventConfidential · Extract
Technical due diligence · Verdict page
Asset X — in-licensing readiness for the EU
Verdict
Proceed, with conditions. Two items must be resolved before signing; one is a timeline risk, not a deal breaker.
Science & mechanism
CMC & impurities
Regulatory path
Market & access
Plan realism
Sourced · structured · verdict firstp. 2 / 38
Sample report
The verdict comes first. Not on page forty.
A firm selling diligence will itself be diligenced. So here is what you actually receive.
- Verdict page up front — a clear call your investment committee can act on.
- Every claim sourced — traceable to documents, data or cited references.
- Recommendations, not just findings — and the next step after the report.
Case studies
Challenge. Approach. Result.
Client engagements stay anonymised unless the client has approved naming in writing.
China diagnostics turnaround
ChallengeA diagnostics company’s China business needed restructuring.
ApproachCross-functional assessment, then a change plan — a model Assess–Decide–Deliver story.
ResultA restructuring path towards a US$200 million sales target.
Digital content delivery
ChallengeA world-leading pump manufacturer needed product information delivered digitally.
ApproachEnterprise change programme for digital content delivery, built on a business case.
ResultBusiness case reaching break-even in year one.
Global agile transformation
ChallengeA global organisation needed delivery to change across teams and sites.
ApproachChange Managed® as the delivery engine — facts first, people aligned, change seen through.
ResultShortened rewrite in progress — outcome figures to follow from the case file.
Client voices
Short testimonials from diligence and research clients — named by sector if not by company.
“
Testimonial slot — quote to be collected with written permission.
“
Testimonial slot — quote to be collected with written permission.
“
Testimonial slot — quote to be collected with written permission.
The Europe–China corridor
On-site presence in Hong Kong, Shanghai and Germany on a rolling basis.
Hong Kong Deal & investor hub
Contracting entity. Buyers here value diligence track record, speed and independence.
Mainland China Where assets originate
Where assets, suppliers and start-ups originate; NMPA, VBP and on-site work. Valued: Pfizer China and diagnostics turnaround track record, consular and embassy references, and the Chinese name 龙立德.
Germany / EU Regulatory destination
Home of med-tech and pharma SMEs. Valued: Dr. rer. nat., Bayer and regulatory credentials, MDR, PFAS and impurity expertise.
Dr. Alexander KuhlFounder & Managing Director
龙立德Chinese name
About the founder
Hands-on product development + independent assessment.
Dr. Alexander Kuhl has spent 25 years across the full value chain of regulated products: medicinal chemistry at Bayer (including lead optimisation work on the compound that became finerenone, marketed as Kerendia®), CMC regulatory affairs for biologics, global project and lifecycle management, partnering at Roche, building Pfizer China’s portfolio and project management function, and directing engineering project management for dialysis solutions, containers and disposables at Fresenius Medical Care.
As an independent consultant he has led long-term engagements for OEMs as change management and project lead on data management, product lifecycle management (PLM) and product information management (PIM). Today his firm also produces due diligence and market research reports for clients in Europe and Asia. He has lived and worked in China for more than 15 years.
12/2023 – present
Managing Director, Prometheus Innovent Ltd., Hong Kong
Due diligence, market research, change, product data and DPP work
10/2016 – 11/2023
Independent consultant, Shanghai
Incl. diagnostics China assessment, Hepalink opportunity analysis, German Consulate General
05/2018 – 10/2022
Director Engineering Project Management, Fresenius Medical Care R&D, Shanghai
Impurity and materials compliance, PLM, portfolio
02/2016 – 08/2016
Sr. Director, Head of Portfolio & Project Management, Pfizer China R&D
Building development organisations
2013 – 2015
Roche China: Business Development Manager a.i.; Line Manager Clinical Operations
Partnering, clinical operations
02/2012 – 02/2013
Director, Head of Clinical Project Management East Asia, UCB Pharma
Regional organisation building
2006 – 2011
Bayer HealthCare: Global Project Leader, later Director Global Project Management (Wuppertal, Beijing)
Development, lifecycle, licensing
2005 – 2006
Project Leader Regulatory Affairs, Bayer Vital
CMC, biologics, EU procedures
2000 – 2005
Laboratory Head and Project Coordinator, Medicinal Chemistry, Bayer
Drug discovery (finerenone)
1995 – 2000
Dr. rer. nat. TU Dortmund; Research Fellow, University of Glasgow
Scientific foundation
Why the ginkgo
A leaf from a Chinese tree, made famous in Germany by a poem about East and West.
The ginkgo is native to China and became a German cultural symbol through Goethe. In 1815 he wrote the poem Gingo biloba about the leaf’s duality, later published in his West-östlicher Divan. Two halves forming one whole — a natural emblem for a firm working between Europe and China, and joining insight with action.
For Chinese readers, the ginkgo (银杏) is a familiar symbol of endurance and longevity.
Ist es Ein lebendig Wesen,
Das sich in sich selbst getrennt?
Sind es zwei, die sich erlesen,
Daß man sie als Eines kennt? J. W. von Goethe · Gingo biloba · 1815 [9]
Clear boundaries
What we are not.
A syndicated market-report publisher
Every study is commissioned, scoped to the client’s decision and ends in recommendations.
A testing laboratory
We decide what should be tested and how results land in the file; laboratories are partners.
A generic agile or change-coaching firm
Change Managed® is the delivery engine, not the product.
An EU Authorised Representative or Notified Body
Where clients need these, we work with partners.
Change Managed®
Change Managed® method
Change Managed® is how we turn insight into action: we establish the facts, align the people who must act on them, and see the change through.
In Insights
Every assessment considers the organisation and the stakeholders who must act — not only the data.In Action
It ensures adoption. Pure research firms do the first half, implementation consultancies the second. Very few do both.C2ALM©Our proprietary framework — an amalgamation of Agile, Lean, Flow, Theory of Constraints, Systems Thinking and Customer Centricity. Tap a discipline to see its role.
C2ALM©for readers who want depth
Perspectives
Briefings written in the founder’s voice.
Checklists, whitepapers and sample extracts — practical tools for the decision in front of you.
Sample extract
What a verdict-first due diligence report looks like
An anonymised extract from a real engagement.
Request extractInvestors
Licensing a China-origin asset: a technical diligence checklist for investors
Download checklistMed-tech
Selecting and qualifying manufacturing suppliers for medical device components: criteria that matter
DownloadQuality heads
Why nitrosamine risk assessments stall — and how to get them to closure
Read briefingMed-tech
PFAS in device consumables: a substitution decision framework
Download frameworkOEMs
Is your product data ready for the Digital Product Passport?
Refreshed whitepaper.
Download whitepaperOEMs
Why PLM and PIM implementations stall — the change management gap
Read briefingAll readers
Newsletter archive
Every past briefing, by audience and language.
Browse archive
Let’s get your project moving forward
Book a 30-minute discovery call.
Confidential, founder-led and specific to your decision. Pick a day — booking is handled through Zoho Bookings.
Dr. Alexander Kuhl30 min · video call · HKT / CET
Select an available dayOpen booking
Hong KongPrometheus Innovent Ltd.
Unit 2A, 17th Floor, Glenealy Tower,
No. 1 Glenealy, Central, Hong Kong
Unit 2A, 17th Floor, Glenealy Tower,
No. 1 Glenealy, Central, Hong Kong
ShanghaiOn-site presence on a rolling basis
Chinese name: 龙立德
Chinese name: 龙立德
GermanyOn-site presence on a rolling basis
Deutsch: formelle Ansprache (Sie)
Deutsch: formelle Ansprache (Sie)