QAdvis
Aurevia is a Swedish consulting firm providing quality assurance, regulatory affairs, and clinical research services to pharmaceutical, biotech, medical device, and IVD companies across Europe. It operates through CRO, QARA, and Aurevia Academy training service lines, with 100+ professionals serving roughly 200 clients annually.
- Company typePrivate
- Founded2000
- HeadquartersStockholm, Sweden
- Headcount11–50
- GTM typeB2B
- OfferingServices
What QAdvis does
QAdvis, operating commercially as Aurevia, is a European consulting firm headquartered in Uppsala, Sweden, specializing in quality assurance, regulatory affairs, and clinical research services for the pharmaceutical, biotechnology, medical device, and in vitro diagnostic (IVD) industries. The company was originally founded in 2000 as Scandinavian CRO and rebranded to Aurevia in 2015 to reflect an expanded service portfolio beyond traditional CRO work. It now operates two core service lines — Clinical Research CRO Services (clinical operations, project management, pharmacovigilance, medical writing, data management, biostatistics, and adjudication across all trial phases) and Quality Assurance & Regulatory Affairs (QARA) Services (regulatory strategy, market registrations in EU/UK/US, technical documentation, clinical/performance evaluation, vigilance, and post-market surveillance) — supported by the Aurevia Academy training sub-brand and the Lean Entries e-tool.
The business operates on a professional services model, with revenue generated through project-based, quote-priced consulting engagements, supplemented by training course fees and e-tool licensing. Go-to-market is sales-led and consultative, targeting enterprise pharma/biotech clients as well as mid-market medical device and IVD manufacturers, with additional work for academic medical centers. The customer base spans global pharma majors (Novartis, AstraZeneca, Johnson & Johnson, Boehringer Ingelheim, Shionogi), Nordic and European mid-market medtech firms (iCare, Reagena, Mylab, Vivago, Nightingale Health, NE Device SW, Forsante), and a long tail of smaller biotech and academic clients, totaling roughly 200 annual clients and 1,000+ projects over the firm's 25-year history.
Aurevia is a privately held, management/founder-controlled firm with no disclosed external funding, no parent company, and no subsidiaries. The company is differentiated primarily by deep regulatory expertise (including offering regulated roles such as European Authorised Representative, UK Responsible Person, and Person Responsible for Regulatory Compliance), and by an experienced bench of 100+ quality, regulatory, and clinical research professionals. Strategic positioning has shifted modestly toward productization via Aurevia Academy and Lean Entries, and toward ecosystem visibility through a 2027 partnership with RAPS for the Medtech Compliance Forum.
QAdvis firmographics
Firmographics- Name
- QAdvis
- Legal name
- Aurevia
- Website
- https://qadvis.com
- Company type
- Private
- Founded year
- 2000
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Aurevia is a Swedish consulting firm providing quality assurance, regulatory affairs, and clinical research services to pharmaceutical, biotech, medical device, and IVD companies across Europe. It operates through CRO, QARA, and Aurevia Academy training service lines, with 100+ professionals serving roughly 200 clients annually.
- Ownership category
- akta.pro rank
QAdvis industry classification
Industry- Product category
- Regulatory Affairs and Clinical Research Consulting
- NAICS
- Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169), Other Scientific and Technical Consulting Services (541690)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industries
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)
Keywords
Where QAdvis is headquartered
LocationHeadquarters
- HQ city
- Stockholm
- HQ country
- Sweden
- HQ region
- Europe
Offices1 record
Markets served
QAdvis business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- CRO Clinical Research Services: Full-service CRO clinical trial services for pharma and biotech covering all phases of clinical development, including clinical operations, project management, pharmacovigilance, medical writing, data management, and biostatistics.
- Quality Assurance and Regulatory Affairs Consulting: Quality assurance and regulatory affairs services covering the lifecycle of medical devices and IVD devices, including regulatory strategy, market registrations, technical documentation, clinical evaluation, and QMS services.
- Training Services (Aurevia Academy): Professional training services within quality assurance, regulatory affairs, and clinical research including seminars, online courses, and tailored training programs.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels7 records
QAdvis product offering
Product offeringCore offering
Aurevia provides Medtech quality and system management, risk management, regulatory affairs, compliance, training, interim management, and clinical research CRO services. Its core offering consists of two integrated service lines: Clinical Research CRO Services (clinical operations, project management, pharmacovigilance, medical writing, data management, biostatistics across all phases) and Quality Assurance & Regulatory Affairs (QARA) Services covering the entire lifecycle of medical devices and IVD devices (regulatory strategy, market registrations, technical documentation, clinical evaluation, post-market surveillance). These are complemented by the Aurevia Academy training program and the Lean Entries e-tool for regulatory strategy.
Product overview
Aurevia is a consulting services firm offering a portfolio of interconnected professional services for the healthcare, pharmaceutical, and medical technology sectors. The core offering consists of two main service lines: Clinical Research CRO Services (covering clinical operations, project management, pharmacovigilance, data management, biostatistics, and medical writing) and Quality Assurance & Regulatory Affairs (QARA) Services (covering regulatory strategy, market registrations, technical documentation, clinical evaluation, and post-market surveillance). Supporting these core services are Aurevia Academy (professional training including seminars, online courses, and tailored programs) and Lean Entries (an e-tool for converting regulatory requirements into actionable strategies). The company also provides specialized services in pharmacovigilance, medical device software consulting, and European/UK regulatory representation.
Differentiator
Problem solved
Functional benefit
Brands
- Aurevia Academy: Professional training services within quality assurance, regulatory affairs, and clinical research including seminars, online courses, and tailored training programs.
- Lean Entries
Products and services
- Clinical Research CRO Services Full-service contract research organization (CRO) supporting pharmaceutical, biotechnology, and medical device/IVD sponsors plus academia to design and conduct clinical research across all phases, including clinical operations, clinical project management, clinical adjudication, pharmacovigilance, medical writing, data management, biostatistics, equipment rental, investigator-initiated trials, and outsourcing solutions.
- Quality Assurance & Regulatory Affairs (QARA) Services Quality assurance and regulatory affairs consulting covering the full lifecycle of medical devices and IVD medical devices, including regulatory strategy, market registrations, European Authorised Representative (EAR), UK Responsible Person (UKRP), digital health and cybersecurity, technical documentation, clinical evaluation, performance evaluation, biological evaluation, risk management, usability engineering, due diligence, PRRC, QMS services, eQMS solutions, US FDA QMSR, medical device development environments, auditing services, and post-market surveillance.
- Aurevia Academy Professional training services within quality assurance, regulatory affairs, and clinical research including standard seminars, online courses, and tailored corporate training programs for pharma, biotech, and medtech organizations, accessible via the Aurevia Academy learning portal.
- Lean Entries E-tool that helps turn complex regulatory requirements into actionable strategies for medtech and life sciences clients.
Companies that use QAdvis
Customer profileNamed customers22 records
Segments4 records
Ideal customer profiles5 records
QAdvis technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
QAdvis partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- RAPS (Regulatory Affairs Professionals Society)corePartnership with RAPS to strengthen medtech regulatory compliance expertise. Co-organizing Medtech Compliance Forum as part of Labquality Days: 11-12 February 2027. This partnership combines Aurevia's expertise in medical device regulatory affairs with RAPS' professional society network.
Scale indicators4 records
Recent moves5 records
Expansion highlights4 records
QAdvis competitors and assessment
Company assessmentDirect peers
- ProPharma Group: Global regulatory, compliance, and pharmacovigilance consulting firm serving pharma and medtech across the product lifecycle — directly comparable to Aurevia's CRO plus QARA service mix and enterprise customer base.
- PharmaLex: Regulatory affairs and pharmacovigilance consulting/CRO serving pharma and medtech globally; closely comparable in regulated services portfolio to Aurevia, with similar EU MDR/IVDR positioning.
- QbD Group: Benelux-headquartered consulting and CRO group focused on quality, regulatory, and clinical services for medtech, pharma, and biotech — directly mirrors Aurevia's Nordic-focused multi-disciplinary consulting model.
- RQM+: Medtech regulatory and quality consulting firm specializing in EU MDR/IVDR, FDA, and global submissions, plus clinical and post-market services — a tight direct peer on Aurevia's medtech QARA offering.
- Qserve Group: Dutch medtech-focused regulatory, quality, and clinical consulting firm with deep EU MDR expertise — comparable niche specialization and customer mix to Aurevia's medtech practice.
- TFS International: European-headquartered CRO delivering clinical, regulatory, and pharmacovigilance services to pharma and medtech companies — closely aligned with Aurevia's clinical research CRO offering and Nordic roots.
Broad incumbents
- ICON plc: One of the world's largest CROs providing full-service clinical development, regulatory, and consulting; represents the global incumbent against which mid-tier European CROs like Aurevia compete for enterprise mandates.
- Parexel International: Major global CRO offering clinical, regulatory, and real-world evidence services across pharma and medtech — sets the competitive ceiling on enterprise deals that Aurevia's pharma/biotech clients also run.
- Charles River Laboratories: Global contract research organization spanning discovery, safety, and clinical development — a broad incumbent comparable to Aurevia on the preclinical/clinical research side.
- TÜV SÜD: Global testing, inspection, certification, and notified body organization providing medtech regulatory and quality services including ISO 13485 and MDR — a broader incumbent adjacent to Aurevia's regulatory/QA service line.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
QAdvis social profiles
Digital presenceQAdvis financial estimates
Financial estimateRevenue estimate
Valuation estimate
QAdvis leadership team
Management profileNumber of profiles
Profiles3 records
QAdvis funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
QAdvis 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 QAdvis
What does QAdvis do?
Aurevia provides Medtech quality and system management, risk management, regulatory affairs, compliance, training, interim management, and clinical research CRO services. Its core offering consists of two integrated service lines: Clinical Research CRO Services (clinical operations, project management, pharmacovigilance, medical writing, data management, biostatistics across all phases) and Quality Assurance & Regulatory Affairs (QARA) Services covering the entire lifecycle of medical devices and IVD devices (regulatory strategy, market registrations, technical documentation, clinical evaluation, post-market surveillance). These are complemented by the Aurevia Academy training program and the Lean Entries e-tool for regulatory strategy.
Is QAdvis a public or private company?
QAdvis is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was QAdvis founded?
QAdvis was founded in 2000. It employs 11 to 50 people.
Where is QAdvis based?
QAdvis is headquartered in Stockholm, Sweden, in the Europe region.
How does QAdvis make money?
Three revenue lines are on record. CRO Clinical Research Services are the primary driver. The others are quality Assurance and Regulatory Affairs Consulting and training Services (Aurevia Academy).
Who are QAdvis's main competitors?
Direct peers on record are ProPharma Group, PharmaLex, QbD Group, RQM+, Qserve Group and TFS International. Broad incumbents are ICON plc, Parexel International, Charles River Laboratories and TÜV SÜD.
Does QAdvis have an API?
No public API is recorded for QAdvis.
What industry is QAdvis in?
QAdvis's product category is Regulatory Affairs and Clinical Research Consulting. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 5417 and its SIC code is 8731.