Regulated Industries · Enterprise Complexity · Switzerland
Where the stakes
are highest, we deliver.
We operate at the intersection of enterprise technology, process excellence, and regulatory rigour — where generic consultancy falls short and senior expertise is non-negotiable.
Industries Served
8
GxP / FDA Validated
100%
Compliance Frameworks
13+
Failed Go-Lives
0
Life Sciences · 01 / 02
Pharmaceutical & Life Sciences
Regulated ERP for pharma, biotech & medtech.
GxP-validated D365 implementations with GAMP 5 compliance, Swissmedic and FDA readiness, and full CSV documentation as a standard deliverable — not an afterthought. From clinical-stage biotech through to commercial pharma and contract manufacturing.
Pharmaceutical
GxP-validated D365 Finance, Swissmedic compliance, GAMP 5 lifecycle. Full CSV documentation as standard deliverable.
Biotechnology
Scalable D365 architecture from clinical-stage through commercial launch with embedded compliance and audit-ready validation.
MedTech & Medical Devices
ISO 9001, MDR, and FDA validation expertise. Traceability matrix and change control integrated from the first sprint.
Life Sciences
Research, CRO, CDMO, distribution, and commercial operations on D365 — with regulatory compliance designed in from day one.
GAMP 521 CFR Part 11EMA Annex 11SwissmedicIQ/OQ/PQISO 13485
Financial Services & M&A
SOX, IFRS, and deal-pressure delivery.
SOX-ready D365 Finance with ITGC frameworks, segregation of duties, and IFRS 15/16 dual reporting — built for external audit from day one. Plus carve-out, spin-off, and post-merger D365 integrations under compressed commercial timelines.
Financial Services
SOX-ready D365 Finance with ITGC frameworks, segregation of duties, IFRS 15/16 dual reporting, and external audit support.
Private Equity & M&A
Carve-outs, spin-offs, and post-merger D365 integrations under compressed deal timelines. TSA exit methodology built for 90-day windows.
Swiss GAAP & FINMA
Swiss GAAP FER, FINMA compliance, and Swiss holding structures — with Swissmedic and nDSG as standard reference frameworks.
SOX / Sarbanes-OxleyITGCIFRS 15/16Swiss GAAP FERFINMATSA Exit
Finance & M&A · 02 / 02
All Industries
Eight industries.
One delivery standard.
Regulated industries and enterprise complexity — where senior expertise and process-first methodology make the difference.
01
GxP · GAMP 5
Pharmaceutical
Pharma & Drug Manufacturing
GxP-validated D365 Finance with Swissmedic and FDA readiness, GAMP 5 lifecycle, and full CSV documentation as a standard deliverable.
GAMP 5SwissmedicFDAIQ/OQ/PQ
02
Clinical → Commercial
Biotechnology
Biotech & Gene Therapy
Scalable D365 architecture from clinical-stage through commercial launch. Embedded compliance so validation grows with your organisation.
21 CFR Part 11EMA Annex 11GxP
03
ISO 13485 · MDR
MedTech & Medical Devices
Medical Device Manufacturers
ISO 9001, MDR 2017/745, and FDA 510(k) validation expertise. Traceability matrix and change control integrated from the first sprint.
ISO 13485MDR 2017/745FDA 510(k)
04
CRO · CDMO · CMO
Life Sciences
Research & Contract Organisations
CROs, CDMOs, and CMOs on D365 — regulatory compliance designed in for research, manufacturing, and commercial distribution.
GxP / CSVSwissmedicGDPR
05
SOX · IFRS
Financial Services
Regulated Finance & Banking
SOX-ready D365 Finance with ITGC frameworks, segregation of duties, IFRS 15/16 dual reporting, and external audit support from day one.
SOXITGCIFRS 15/16Swiss GAAP
06
ISO 9001 · Lean
Manufacturing
Complex Multi-Site Manufacturing
D365 SCM, warehouse management, and production planning for complex, multi-site manufacturing environments with MES integration.
ISO 9001D365 SCMWMSMES
07
Carve-outs · TSA Exit
Private Equity & M&A
Carve-outs, Spin-offs & Mergers
Standalone D365 go-lives under deal timelines. We design the target operating model before standing up the environment — efficient from day one.
TSA ExitTOM DesignData Sovereignty
08
PSA · T&M
Professional Services
Project-Based & Services Firms
Project-based ERP, time & materials billing, resource management, and professional services automation on D365 F&O.
PSAT&M BillingResource Mgmt
Compliance Frameworks
Built for the most demanding regulatory environments.
Validation
GAMP 5
Good Automated Manufacturing Practice — the gold standard for computerised system validation in life sciences.
FDA
21 CFR Part 11
Electronic records and signatures compliance for FDA-regulated environments on D365.
EMA
EMA Annex 11
European Medicines Agency guidelines for computerised systems in GxP environments.
Swiss
Swissmedic
Swiss regulatory authority requirements for medicinal products and medical devices.
Finance
SOX / Sarbanes-Oxley
Section 302 and 404 compliance built into D365 Finance control architecture from day one.
Reporting
Swiss GAAP FER
Swiss GAAP FER and IFRS 15/16 dual reporting structures in D365 Finance.
Quality
ISO 9001 & 13485
Quality management system requirements for manufacturing and medical device organisations.
Devices
MDR 2017/745
EU Medical Device Regulation — traceability, post-market surveillance, and UDI requirements.
Our Regulated Industry Record
Depth of expertise, breadth of delivery.
8
Industries Served
From pharma and medtech to financial services, manufacturing, and PE-backed carve-outs.
13+
Compliance Frameworks
GAMP 5, 21 CFR Part 11, SOX, MDR, ISO 9001/13485, Swiss GAAP, IFRS — embedded, not retrofitted.
100%
GxP / FDA Validated
Every life sciences engagement delivered with GAMP 5 compliance and full CSV documentation.
0
Failed Go-Lives
Process-first methodology means we fix the business process before configuring a single module.
Ready to Start?
Your industry is our speciality.
Senior consultants with deep regulatory domain expertise. A clear picture of where your processes stand and what your D365 investment should look like — before any commitment.