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
- Pharma, MedTech, and IVD companies
- Companies seeking full-life cycle regulatory and operational support
How engagement typically works
- Strategic partnership
- Full-life cycle support
Typical deliverables
- Regulatory compliance strategies
- Operational excellence improvements
- Validation services (process, cleaning, analytical, sterilization)
- Commissioning and qualification support
Good to know
- Best when requiring specialized expertise in Life Sciences regulation and quality.
HQ:
Antwerp, BE
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Find 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
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