Qdossier
Qdossier is a private Netherlands-based pharmaceutical regulatory documentation specialist, founded in 2006 and headquartered in Waalwijk, that focuses on the efficient recording and exchange of proof of quality, safety, and efficacy of medicinal products for drug manufacturers and regulators.
- Company typePrivate
- Founded2006
- HeadquartersWaalwijk, Netherlands
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
Qdossier firmographics
Firmographics- Name
- Qdossier
- Website
- https://qdossier.com
- Company type
- Private
- Founded year
- 2006
- Headcount range
- 11–50 employees
- Short description
- Qdossier is a private Netherlands-based pharmaceutical regulatory documentation specialist, founded in 2006 and headquartered in Waalwijk, that focuses on the efficient recording and exchange of proof of quality, safety, and efficacy of medicinal products for drug manufacturers and regulators.
- Ownership category
- akta.pro rank
Qdossier industry classification
Industry- Product category
- Pharmaceutical Regulatory Documentation
- akta.pro primary industry
- Value Dossier & Evidence Generation (AMCP/Global Value Dossier) (HLAIAKAC)
- akta.pro secondary industries
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)
Keywords
Where Qdossier is headquartered
LocationHeadquarters
- HQ city
- Waalwijk
- HQ country
- Netherlands
- HQ region
- Europe
Markets served
Qdossier business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Others
Qdossier product offering
Product offeringCore offering
Qdossier provides a service focused on the efficient recording and exchange of documentation proving the quality, safety, and efficacy of medicinal products. The offering is aimed at pharmaceutical regulatory workflows where sponsors, manufacturers, and regulators must compile and share structured product dossiers.
Differentiator
Problem solved
Functional benefit
Products and services
- Qdossier dossier recording and exchange service A service that enables the recording and exchange of documentation proving the quality, safety, and efficacy of medicinal products, intended for pharmaceutical sponsors, manufacturers, and regulatory affairs teams managing regulatory dossiers.
Companies that use Qdossier
Customer profileIdeal customer profiles1 record
Qdossier technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Qdossier competitors and assessment
Company assessmentBroad incumbents
- Parexel International: Parexel is a global CRO offering regulatory consulting, dossier authoring, and submission services. It overlaps with Qdossier's regulatory documentation work and is the type of scaled competitor that may pressure niche dossier specialists.
- IQVIA: IQVIA is a large CRO and life sciences services firm whose regulatory affairs practice includes dossier preparation, submission management, and pharmacovigilance documentation. It competes with Qdossier across the regulatory documentation workflow as part of a much broader portfolio.
- ICON plc (PRA Health / DOCS): ICON provides regulatory and clinical services to pharma, including submission and dossier support functions. As a global CRO with broad capabilities, it represents an incumbent option for clients who might otherwise engage a niche dossier specialist like Qdossier.
- DXC Technology (CSC Life Sciences): DXC Technology (via the former CSC Life Sciences unit) provides regulatory information management and submission software to pharma. Its broader IT services portfolio positions it as an incumbent alternative to smaller dossier specialists like Qdossier.
Direct peers
- Veeva Systems: Veeva's Vault RIM platform manages regulatory information, submissions, and dossiers for life sciences customers. It directly overlaps with Qdossier's focus on recording and exchange of quality, safety, and efficacy documentation for medicinal products.
- PharmaLex: PharmaLex (now part of Cencora) provides regulatory affairs consulting and dossier services to pharma companies. It serves the same customer need as Qdossier - compiling and managing quality/safety/efficacy submissions.
- ArisGlobal: ArisGlobal provides life sciences regulatory, safety, and pharmacovigilance software, including solutions for document management and dossier submissions. Its regulatory information management product competes in the same workflow Qdossier addresses.
- Arriello: Arriello provides regulatory affairs, compliance, and pharmacovigilance services for life sciences, including documentation and dossier support. It is a similarly-sized European specialist that competes for the same kinds of mid-market biopharma engagements as Qdossier.
- Generis (RIM/Regulatory Data Management): Generis provides the CARA regulatory information management platform used by pharma for dossier, submission, and product registration management. It competes head-on with Qdossier's recording and exchange value proposition.
- LORENZ Life Sciences: LORENZ offers the docuBridge suite for electronic regulatory submissions and dossier publishing. It serves the same eCTD/dossier exchange workflow that Qdossier supports for pharmaceutical sponsors.
Market position
Customer concentration
Qdossier financial estimates
Financial estimateRevenue estimate
Valuation estimate
Qdossier leadership team
Management profileNumber of profiles
Qdossier funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Qdossier 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 Qdossier
What does Qdossier do?
Qdossier provides a service focused on the efficient recording and exchange of documentation proving the quality, safety, and efficacy of medicinal products. The offering is aimed at pharmaceutical regulatory workflows where sponsors, manufacturers, and regulators must compile and share structured product dossiers.
When was Qdossier founded?
Qdossier was founded in 2006. It employs 11 to 50 people.
Where is Qdossier based?
Qdossier is headquartered in Waalwijk, Netherlands, in the Europe region.
Who are Qdossier's main competitors?
Broad incumbents on record are Parexel International, IQVIA, ICON plc (PRA Health / DOCS) and DXC Technology (CSC Life Sciences). Direct peers are Veeva Systems, PharmaLex, ArisGlobal, Arriello, Generis (RIM/Regulatory Data Management) and LORENZ Life Sciences.
Does Qdossier have an API?
No public API is recorded for Qdossier.
What industry is Qdossier in?
Qdossier's product category is Pharmaceutical Regulatory Documentation. Its primary akta.pro industry code is HLAIAKAC, Value Dossier & Evidence Generation (AMCP/Global Value Dossier), with a secondary code of HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation.