QbD Group
★★★★★
4.3
/ 5
•
20 reviews
QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence. They offer full-life cycle support for pharma, MedTech, and IVD companies.
QbD Group is a strategic partner in Life Sciences, dedicated to accelerating innovation from idea to patient and ensuring confident growth through regulatory compliance and operational excellence. With over 600 professionals, they provide full-life cycle support for start-ups, scale-ups, and global leaders in pharma, MedTech, and IVD. Their services encompass a wide range of expertise, including Regulatory Affairs, Quality Assurance, Lab Services, Qualification & Validation, Vigilance, Clinical Solutions, Software Solutions, and Toxicology. They specialize in helping global Pharma and MedTech companies enter and thrive in Europe, offering deep GxP know-how, regulatory strategy, clinical evidence, and importation expertise. QbD Group prides itself on delivering tailored, cost-effective solutions with lean project setups and solid project management. Their hands-on teams take ownership, solve problems proactively, and deliver high-quality results efficiently and effectively, embedding into client teams with flexibility and transparency to drive shared success and build long-term partnerships.
About
**Who they are**
QbD Group is a strategic partner for Life Sciences companies, focusing on accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence. They offer full-life cycle support for pharma, MedTech, and IVD companies.
**Expertise & scope**
* Acts as a Swiss Authorised Representative (CH-REP), serving as the official point of contact with Swissmedic.
* Verifies manufacturer's Declaration of Conformity and technical documentation.
* Retains copies of technical documentation and certificates for at least 10 years.
* Provides regulatory affairs services for pharma and medical devices.
* Offers quality assurance services to ensure products are market-ready and compliant.
* Provides qualification and validation services for equipment, facilities, and processes.
* Offers comprehensive analytical testing through a GMP-certified laboratory.
* Specializes in clinical solutions for medical devices and IVDs, acting as a Contract Research Organization (CRO).
**Reputation / proof points**
* Over 25 years of experience in Lab Services.
* More than a decade of expertise in Qualification & Validation services with a team of over 600 specialists.
* Over 20 years of experience in clinical development for medical devices and IVDs.
QbD Group is a strategic partner for Life Sciences companies, focusing on accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence. They offer full-life cycle support for pharma, MedTech, and IVD companies.
**Expertise & scope**
* Acts as a Swiss Authorised Representative (CH-REP), serving as the official point of contact with Swissmedic.
* Verifies manufacturer's Declaration of Conformity and technical documentation.
* Retains copies of technical documentation and certificates for at least 10 years.
* Provides regulatory affairs services for pharma and medical devices.
* Offers quality assurance services to ensure products are market-ready and compliant.
* Provides qualification and validation services for equipment, facilities, and processes.
* Offers comprehensive analytical testing through a GMP-certified laboratory.
* Specializes in clinical solutions for medical devices and IVDs, acting as a Contract Research Organization (CRO).
**Reputation / proof points**
* Over 25 years of experience in Lab Services.
* More than a decade of expertise in Qualification & Validation services with a team of over 600 specialists.
* Over 20 years of experience in clinical development for medical devices and IVDs.
Additional information
QbD Group's CH-REP service acts as a crucial link between non-Swiss manufacturers and Swissmedic. They ensure that required documentation is available for inspection and support manufacturers in navigating Swiss regulatory requirements. Their onboarding process is designed to be a 3-step approach, aiming for efficient integration. They also offer support for both EU and Swiss regulatory requirements, potentially allowing a single partner to manage both.
Key Highlights
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QbD Group acts as a Swiss Authorised Representative (CH-REP), serving as the official point of contact with Swissmedic.
Source
“A Swiss Authorised Representative (CH-REP) is a natural or legal person based in Switzerland who acts on behalf of a non-Swiss manufacturer. The CH-REP serves as the official point of contact with Swissmedic”
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They retain copies of technical documentation and certificates for at least 10 years.
Source
“Retain copies of your technical documentation and certificates for at least 10 years”
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Offers full-life cycle support for pharma, MedTech, and IVD companies.
Source
“We support our clients through every stage of the drug and medical device regulatory lifecycle.”
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Possesses over 20 years of experience in clinical development for medical devices and IVDs.
Source
“With over 20 years of experience, we specialize in designing and managing clinical studies, ensuring regulatory compliance, and accelerating your path to market.”
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Their Lab Services division has over 25 years of experience providing analytical solutions.
Source
“With over 25 years of experience, QbD Group’s Lab Services provides high-quality analytical solutions tailored to the pharmaceutical industry.”
Certifications & Trust Signals
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QbD Group has over 600 specialists contributing to their Qualification & Validation services.
Source
“QbD Group brings more than a decade of expertise and a team of +600 specialists to every project.”
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Their GMP-compliant laboratory ensures high-quality analytical testing.
Source
“Our GMP-compliant laboratory combines efficient turnaround times, competitive pricing, and a flexible, personalized approach.”
Buyer Snapshot
Best for
- Companies seeking a Swiss Authorized Representative (CH-REP).
- Life Sciences manufacturers needing regulatory affairs support.
- MedTech and IVD companies requiring clinical trial management.
How engagement typically works
- Acts as an extension of the client's team.
- Provides personalized support throughout the product lifecycle.
- Offers clear, real-time updates on project progress and budget.
Typical deliverables
- Designated Swiss Authorized Representative (CH-REP).
- Retained technical documentation and certificates.
- Regulatory compliance strategies.
- Clinical study management.
- Analytical testing reports.
Good to know
- Best when local Swiss representation and direct communication with Swissmedic are required.
HQ:
Antwerp, BE
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
100+
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
IVD
Vigilance Contact Support:
Yes
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
A 3-step onboarding process is mentioned.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (implied by MedTech/IVD support)
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Switzerland
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes (implied by CH-REP role)
