FGK Representative Service
FGK Representative Service GmbH
FGK Representative Service GmbH offers comprehensive clinical research support, specializing in representing medicinal products within the European Union, Switzerland, and the UK. With nearly two decades of experience, they ensure compliance with legal obligations and provide full-service clinical d
FGK Representative Service GmbH is a dedicated provider of clinical research services, focusing on representing medicinal products across the European Union, Switzerland, and the UK. With close to two decades of experience, they are adept at navigating the complexities of product vigilance and ensuring adherence to all legal obligations required by competent authorities. As a full-service Contract Research Organization (CRO), FGK offers a complete spectrum of clinical development and consulting services tailored for pharmaceutical, biotechnology, and medical device companies. Their expertise is particularly valuable for smaller and middle-sized companies seeking a reliable partner for their product development journey. FGK is committed to addressing the unique challenges of each project and meeting unmet needs within the rapidly evolving field of clinical research. Their team is driven by the motivation to contribute to the development of new therapies and provide exceptional support to their clients.
About
**Who they are**
FGK Representative Service GmbH is an experienced provider specializing in representing medicinal products within the European Union, Switzerland, and the UK. With nearly two decades of experience, they focus on ensuring compliance with legal obligations for their clients.
**Expertise & scope**
* Representation of medicinal products in the European Union, Switzerland, and the UK.
* Support for product vigilance to meet legal obligations to competent authorities.
* Services tailored for smaller and middle-size biotech, pharmaceutical, or medical device companies.
**Reputation / proof points**
* Nearly two decades of experience in the field.
FGK Representative Service GmbH is an experienced provider specializing in representing medicinal products within the European Union, Switzerland, and the UK. With nearly two decades of experience, they focus on ensuring compliance with legal obligations for their clients.
**Expertise & scope**
* Representation of medicinal products in the European Union, Switzerland, and the UK.
* Support for product vigilance to meet legal obligations to competent authorities.
* Services tailored for smaller and middle-size biotech, pharmaceutical, or medical device companies.
**Reputation / proof points**
* Nearly two decades of experience in the field.
Additional information
FGK Representative Service GmbH offers comprehensive support for product vigilance, ensuring clients meet their legal obligations to regulatory authorities. Their services are particularly beneficial for smaller and medium-sized biotech, pharmaceutical, and medical device companies seeking to navigate the complexities of market representation within the EU, Switzerland, and the UK. The company emphasizes a full-service approach to clinical research support and regulatory compliance.
Key Highlights
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Represents medicinal products in the European Union, Switzerland, and the UK.
Source
“With nearly two decades experience, we represent your medicinal product business in the European Union, Switzerland and the UK.”
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Supports product vigilance to meet legal obligations to competent authorities.
Source
“We support you in every aspect of your product vigilance to meet your legal obligations to competent authorities.”
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Ideal size for cooperation with smaller and middle-size biotech, pharmaceutical or medical device companies.
Source
“FGK Clinical Research is an owner-driven CRO of an ideal size for cooperation with smaller and middle-size biotech, pharmaceutical or medical device companies.”
Certifications & Trust Signals
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Nearly two decades of experience in the field.
Source
“With nearly two decades experience, we represent your medicinal product business in the European Union, Switzerland and the UK.”
Buyer Snapshot
Best for
- Smaller and middle-sized biotech companies
- Pharmaceutical companies
- Medical device companies
How engagement typically works
- Full-service clinical research support
- Product vigilance support
Typical deliverables
- EU, Switzerland, and UK medicinal product representation
- Compliance with legal obligations
- Support for product vigilance
Good to know
- Best when requiring representation for medicinal products in the EU, Switzerland, and the UK.
HQ:
Munich, Germany
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
Best DSA Legal Representative| Compare & Get Quotes
Jurisdictions:
EU
Countries:
DE, IE
Industries:
Online platforms, Marketplaces, Hosting, SaaS
Portfolio:
1-5, 6-25
Onboarding time:
1–7 days
Pricing model:
Custom pricing
Starting from:
EUR 3,000
Included services:
DSA authority contact point, Notice handling routing, Escalation workflow setup, Coordinator notification support
Languages:
English, German
EU Entity Country:
Germany
Regulator Comms Handling:
Respond with client approval
Additional dsa_art13_rep Details
Platform Size
small, medium
Multi Language Notices
true
EU Entity Country
Germany
