GBA Key2Compliance
GBA Key2Compliance is a Nordic regulatory compliance, quality assurance, and clinical development consultancy acquired by GBA Group in 2024, serving medical device, IVD, and pharmaceutical manufacturers with consulting, CRO services, and professional training across Europe and beyond.
- Company typePrivate
- Founded2020
- HeadquartersStockholm, Sweden
- Headcount11–50
- GTM typeB2B
- OfferingServices
What GBA Key2Compliance does
GBA Key2Compliance AB (formerly Key2Compliance AB) is a Nordic-based regulatory compliance and clinical development consultancy serving medical device, in vitro diagnostic (IVD), and pharmaceutical manufacturers across Europe. Founded around 2020 and wholly owned by GBA Group (Hamburg) since the January 2024 acquisition, the firm operates from Stockholm (HQ), Copenhagen (regional entity Key2Compliance Aps), Gothenburg/Mölndal, and Malmö, delivering services globally with concentration in EU and MENA markets through partner relationships. Its service portfolio spans the full product lifecycle: regulatory affairs (CE marking, technical documentation, global registration, vigilance, post-market surveillance), quality assurance (QMS development, PRRC services, internal audits, Focalcube eQMS technology), clinical development (CRO services covering clinical investigations, performance studies, GCP audits, medical writing), biological safety and toxicology, pharmaceutical QA (GxP compliance), and a multi-format training business (public courses, in-house customized training, on-demand e-learning, and avatar-based compliance training).
The firm monetizes exclusively through professional services: consulting engagements, CRO project fees, and per-participant training pricing ranging from €280 to €2,550 per course. Notable proprietary assets include Focalcube (web-based eQMS integrating CAPA and change management) and an avatar-based internal compliance training format. Notable customers include BOHUS (primary CRO engagement, with downstream reach to 60+ countries), Watson-Marlow Flexicon (interim QA manager support), Prostatype Genomics (IVDR certification), and Envirotainer (customized root cause analysis training), spanning both startups (Prostatype) and enterprise accounts (Watson-Marlow, BOHUS). GTM is sales-led and event-driven, with active participation in Regulatory Summit, MedTech Forum, Medicon Valley Alliance events, SmiLe venture hub (Gold Sponsor), and a partnership with Ironstone Product Development for North American market access. The company does not develop core technology platforms beyond Focalcube eQMS and its avatar training format; its value proposition is expert-led advisory, training, and clinical operations support.
GBA Key2Compliance firmographics
Firmographics- Name
- GBA Key2Compliance
- Legal name
- GBA Key2Compliance AB
- Website
- https://key2compliance.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- GBA Key2Compliance is a Nordic regulatory compliance, quality assurance, and clinical development consultancy acquired by GBA Group in 2024, serving medical device, IVD, and pharmaceutical manufacturers with consulting, CRO services, and professional training across Europe and beyond.
- Ownership category
- akta.pro rank
GBA Key2Compliance industry classification
Industry- Product category
- Regulatory Compliance Consulting
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industries
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF), Medical Writing & Clinical Documentation FSP (HLAGAOAC), Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)
Keywords
Where GBA Key2Compliance is headquartered
LocationHeadquarters
- HQ city
- Stockholm
- HQ country
- Sweden
- HQ region
- Europe
Offices4 records
Markets served
GBA Key2Compliance business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Regulatory Affairs & Quality Assurance Consulting: Professional consulting services including regulatory affairs, quality assurance, PRRC services, due diligence, technical documentation, and QMS support for medical devices, IVDs, and pharmaceutical companies.
- Clinical Development Services (CRO): Clinical development and CRO services including clinical strategy, clinical investigations, performance studies, clinical affairs, medical writing, and GCP audit services.
- Training & Education: Public courses, in-house customized training, on-demand/e-learning courses covering regulatory affairs, quality management, auditing, GMP, GxP compliance, and specialized topics. Courses priced from €280 to €2,550 per participant.
- Biological Safety & Toxicology Services: Biological evaluation, toxicological risk assessment, GLP & ISO 17025 testing coordination, shelf-life evaluation, and sterilization validation services.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | CAPA and Root Cause Analysis Course - 1 day online |
| One time/ perpetual license | Pay-as-you-go | Auditor/Lead Auditor - Pharmaceuticals and Medical Devices - 3 days |
| One time/ perpetual license | Pay-as-you-go | Medical Device Supplier Control and Outsourcing - 2 days |
| One time/ perpetual license | Pay-as-you-go | Change Management for Medical Devices - 1 day |
| One time/ perpetual license | Pay-as-you-go | Risk Management for Medical Devices - ISO 14971 - 2 days |
| One time/ perpetual license | Pay-as-you-go | GMP MasterClass - 2 days |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels6 records
GBA Key2Compliance product offering
Product offeringCore offering
GBA Key2Compliance provides regulatory affairs, quality assurance, clinical development (CRO), biological safety and toxicology consulting, and professional training services for medical device, in vitro diagnostic (IVD), and pharmaceutical manufacturers across the full product lifecycle from concept to market. Services include CE marking, technical documentation, MDR/IVDR compliance, QMS development and audits, PRRC services, clinical investigations, and public/in-house training courses priced per participant.
Product overview
GBA Key2Compliance offers a comprehensive portfolio of regulatory compliance consulting and training services for the MedTech, IVD, and pharmaceutical industries. The company provides expert consulting across regulatory affairs, quality assurance, clinical development/CRO services, biological safety, and pharmaceutical QA. Their training division offers public courses, in-house/customized training, on-demand e-learning, and innovative avatar-based training programs. The company also offers Focalcube eQMS as a technology platform for electronic quality management. Services span the full product lifecycle from concept to market, with specialized expertise in MDR and IVDR compliance for EU market access.
Differentiator
Problem solved
Functional benefit
Products and services
- Regulatory Affairs Services
Quantifiable outcome
- Prostatype Genomics achieved IVDR certification with support from GBA Key2Compliance, securing market access and regulatory credibility
- +2 more outcomes
Companies that use GBA Key2Compliance
Customer profileNamed customers4 records
Segments5 records
Ideal customer profiles4 records
GBA Key2Compliance technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
GBA Key2Compliance partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered flagship, core and minor.
- GBA GroupflagshipIn January 2024, GBA Group (based in Hamburg) acquired Key2Compliance AB, integrating the company into the GBA Group family. The acquisition expanded GBA Group's consulting and training services for medical device, IVD, and pharmaceutical industries. In September 2024, Key2Compliance officially rebranded to GBA Key2Compliance as part of the merger integration.
- Ironstone Product DevelopmentcoreCollaboration agreement with Canadian Ironstone Product Development gives GBA Key2Compliance stronger offering in North America and provides Ironstone stronger offering in Europe. The partnership leverages GBA Key2Compliance's European regulatory expertise with Ironstone's North American market knowledge.
- SmiLe Venture HubminorGBA Key2Compliance is a Gold Sponsor of SmiLe, a leading venture hub specializing in advancing life science startups from concept to commercialization. The partnership supports GBA's commitment to growing small businesses in the MedTech ecosystem.
- Prostatype GenomicscoreGBA Key2Compliance provided regulatory support for Prostatype Genomics' IVDR certification, including technical documentation, QMS enhancements, and strategic decision-making. Prostatype is a Swedish precision medicine company offering genetic diagnostic tests for prostate cancer.
- BOHUSflagshipGBA Key2Compliance serves as the primary CRO for BOHUS, a Swedish company producing high-quality hyaluronic acid products for ophthalmics, aesthetics, and orthopedics. Services include clinical strategy, study design, clinical investigation plans, and project management for clinical investigations from start to finish.
Scale indicators5 records
Recent moves8 records
Expansion highlights5 records
GBA Key2Compliance competitors and assessment
Company assessmentMarket position
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
GBA Key2Compliance social profiles
Digital presenceGBA Key2Compliance financial estimates
Financial estimateRevenue estimate
Valuation estimate
GBA Key2Compliance leadership team
Management profileNumber of profiles
Profiles8 records
GBA Key2Compliance subsidiaries and ownership
Company hierarchySubsidiaries1 record
GBA Key2Compliance funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
GBA Key2Compliance M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about GBA Key2Compliance
What does GBA Key2Compliance do?
GBA Key2Compliance provides regulatory affairs, quality assurance, clinical development (CRO), biological safety and toxicology consulting, and professional training services for medical device, in vitro diagnostic (IVD), and pharmaceutical manufacturers across the full product lifecycle from concept to market. Services include CE marking, technical documentation, MDR/IVDR compliance, QMS development and audits, PRRC services, clinical investigations, and public/in-house training courses priced per participant.
Is GBA Key2Compliance a public or private company?
GBA Key2Compliance is a private company. It is classified as corporate owned and is currently operating.
When was GBA Key2Compliance founded?
GBA Key2Compliance was founded in 2020. It employs 11 to 50 people.
Where is GBA Key2Compliance based?
GBA Key2Compliance is headquartered in Stockholm, Sweden, in the Europe region.
How does GBA Key2Compliance make money?
Four revenue lines are on record. Regulatory Affairs & Quality Assurance Consulting is the primary driver. The others are clinical Development Services (CRO), training & Education and biological Safety & Toxicology Services.
Does GBA Key2Compliance have an API?
No public API is recorded for GBA Key2Compliance.
What industry is GBA Key2Compliance in?
GBA Key2Compliance's product category is Regulatory Compliance Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 54171 and its SIC code is 8731.