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 in Life Sciences, offering regulatory compliance and operational excellence to accelerate innovation and ensure confident growth 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 full-life cycle support for medical devices, IVDs, and pharmaceuticals.
* Offers comprehensive services including Regulatory Affairs, Quality Assurance, Lab Services, Qualification & Validation, Vigilance, and Clinical Solutions.
**Reputation / proof points**
* Possesses over a decade of expertise in Qualification & Validation services with a team of over 600 specialists.
* Operates a GMP-certified laboratory with over 25 years of experience in analytical solutions for the pharmaceutical industry.
QbD Group is a strategic partner in Life Sciences, offering regulatory compliance and operational excellence to accelerate innovation and ensure confident growth 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 full-life cycle support for medical devices, IVDs, and pharmaceuticals.
* Offers comprehensive services including Regulatory Affairs, Quality Assurance, Lab Services, Qualification & Validation, Vigilance, and Clinical Solutions.
**Reputation / proof points**
* Possesses over a decade of expertise in Qualification & Validation services with a team of over 600 specialists.
* Operates a GMP-certified laboratory with over 25 years of experience in analytical solutions for the pharmaceutical industry.
Additional information
QbD Group's CH-REP service focuses on ensuring compliance through local representation and direct communication with Swissmedic. They act as a reliable partner throughout the device lifecycle, managing required documentation and supporting manufacturers in meeting Swiss regulatory requirements. Their onboarding process is structured in three steps, aiming for a seamless transition. They also offer support for both EU and Swiss regulatory requirements, and advise on whether CH-REP details need to appear on labeling.
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 a decade of expertise in Qualification & Validation services with a team of over 600 specialists.
Source
“When it comes to Qualification & Validation services, QbD Group brings more than a decade of expertise and a team of +600 specialists to every project.”
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Operates a GMP-compliant laboratory with over 25 years of experience in analytical solutions for the pharmaceutical industry.
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 is a strategic partner in Life Sciences, accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence.
Source
“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.
Source
“We support our clients through every stage of the drug and medical device regulatory lifecycle.”
Buyer Snapshot
Best for
- Life Sciences companies seeking regulatory compliance
- Pharma, MedTech, and IVD manufacturers
- Companies needing Swiss Authorized Representation
How engagement typically works
- Strategic partnership
- Full-life cycle support
- Focus on accelerating innovation
Typical deliverables
- Regulatory compliance strategies
- Operational excellence guidance
- Swiss Authorized Representative services
Good to know
- Best when requiring specialized support for the Swiss market
Pricing
Model:
Retainer
HQ:
Antwerp, BE
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim 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
Swiss Local Contact:
Yes
Labeling Support:
Yes
Swiss Entity Canton Or Region:
Switzerland
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, Pharma support)
Supports MDR
true
Supports IVDR
true
Swiss Entity Canton Or Region
Switzerland
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Can Be Named On Label
Yes (implied by CH-REP role)
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