Our FBO Services

We can help

Rubicon Technical is a leading provider of FBO (Food Business Operator) services. We offer comprehensive solutions to help food businesses comply with regulations and ensure the safety and quality of their products.

As an FBO, we understand the complex and ever-changing nature of the food industry. That’s why our team of experts stays up-to-date with local, national, and international regulations to provide you with the most relevant and effective services.

What is an FBO?

Rubicon Technical is an FBO. An FBO or Food Business Operator are responsible for ensuring that the food they handle is safe for consumption and meets all necessary regulations and standards.

Why do you need an FBO?

The role of an FBO is crucial in ensuring the safety and quality of our food supply. With the ever-increasing global demand for food, it is vital to have proper systems in place to regulate and monitor the production, handling, and distribution of food products. FBOs play a significant part in this process by following strict guidelines and implementing necessary measures to prevent contamination and ensure food safety.

In addition to ensuring food safety, FBOs also have a responsibility to maintain the quality of their products. FBOs must adhere to standards set by regulatory bodies in terms of packaging, labelling, storage, and transportation of food products.

We can help with:

Batch Release Support

Rubicon’s batch release and support service provides a comprehensive solution for companies seeking to ensure the quality and safety
of their products. Our experienced team will efficiently manage the review of product documentation and testing results, ensuring that all products meet regulatory requirements and quality standards.

Our batch release and support service is built upon our deep understanding of industry regulations and best practices. We maintain strict
adherence to ISO and other globally recognized standards, ensuring that our clients’ products are safe, effective, and legally compliant.

At Rubicon, we strive to help our clients take a proactive approach to quality control and regulatory compliance. Our batch release and support service gives you the confidence to focus on your business and your customers, while we handle the details of batch release and compliance.

Supply of EU and UK Address

Looking to import food or food supplements into the EU or UK? At Rubicon, we offer the use of our registered EU and UK FBO addresses to ensure regulatory compliance.

Our team has extensive experience in food safety and regulatory compliance, including ISO and other globally recognised standards. We work with your business to provide an EU and /or UK FBO address that meet the requirements of regulatory bodies, enabling compliance of products released in market to the local authorities.

Our supply of EU and UK FBO addresses service covers a range of topics, including notifications and authorisations, formulation compliance, labelling requirements, product safety, batch release and much more. We also provide support and guidance to ensure that your products continue to meet all necessary regulatory requirements.

With our reliable and comprehensive supply of EU and UK addresses, your business can import food and food supplements into these markets with confidence, knowing that all necessary regulations and safety standards have been met.

 Regulatory Compliance Checks

Ensuring regulatory compliance is key to managing food, cosmetic and medical device safety and preventing costly penalties. At Rubicon,
our expert team provides reliable regulatory compliance checks in these market sectors. We offer tailored services to help businesses ensure compliance with local and global regulations.

Our regulatory compliance checks cover a wide range of topics, including labelling requirements, safety standards, and ingredient specifications. We work closely with your business to identify and assess any potential compliance issues and develop a customised plan of action to resolve them.

Our regulatory compliance checks are designed to give you peace of mind, knowing that your products meet all relevant regulations to ensure product safety and protect your brand reputation. With our years of experience and our deep understanding of regulatory compliance, we are your trusted partner to help you meet all necessary requirements.

Brexit Advice

Rubicon’s Brexit Advice Service provides essential support to businesses navigating the complex and unprecedented changes brought about by the UK’s departure from the European Union. Our team of experts stay on top of all the latest developments and regulations, helping you to understand and mitigate your Brexit-related risks.

As an ISO 9001 certified company, you can trust that our advice is grounded in rigorous quality standards and best practices. We offer a
range of services, from initial assessments to ongoing monitoring, tailored to your specific needs. Our goal is to help you maintain compliance, minimize disruptions, and seize new opportunities as they emerge.

Compilation of Technical Dossiers

To bring a cosmetic or medical device product to market, you need to compile a technical dossier that outlines details such as product
composition, manufacturing processes, and safety information. At Rubicon, our team of experts provides reliable and comprehensive compilation of technical dossiers to help you navigate this complex process.

Our team has extensive knowledge of cosmetic and medical device safety and regulatory compliance, including ISO and other globally recognised standards. We work with your business to develop a customised technical dossier that meets the requirements of regulatory bodies. 

Our compilation of technical dossiers covers a range of topics, including product development, formulation, and manufacturing processes. We also ensure that all necessary safety and labelling information is included, so you can ensure complete transparency with your customers.

With our comprehensive technical dossier services, your business can ensure that your products meet all relevant regulations and safety standards, while maintaining transparency and credibility in the market. 

EU Notifications and Registrations

Rubicon’s EU notifications and registrations service provides a complete solution for companies seeking to navigate the complex regulatory environment of the EU. Our team of experts manages the entire notification and registration process, ensuring that our clients’ products are fully compliant with relevant regulations and standards.

Our EU Notifications and Registrations service is built upon our deep understanding of the complex and evolving regulatory landscape. We stay up-to-date with the latest regulatory requirements and industry standards, ensuring that our clients remain compliant and informed.

At Rubicon, we understand the importance of maintaining regulatory compliance and facilitating market access for our clients’ products. Our EU Notifications and Registrations service gives you the confidence to focus on your business while we manage the details of regulatory compliance.

Borderlines and Classification

       All medical devices must be classified in accordance with the classification rules in the relevant legislation. The classification of a device is crucial in deciding what route to market applies for your product, and it is a key step in the medical device regulatory process. Classification rules are changing as a result of the MDD/IVDD to MDR/IVDR transition and it is important to correctly classify your device to ensure continued compliance and sales.
 
Medical devices share a borderline with other product types that fall under different regulatory regimes, including medicinal products, cosmetics and biocides. Ensuring your product is compliant with the relevant legislation ensures an unhindered market entry. Rubicon can assist in identifying the correct regulatory framework in borderline cases.

We can help you:

  •         Classify your medical device for the EU and UK markets.
  •        Navigate the borderline between different regulatory frameworks.
  •        Understand the legal obligations for your product to help ensure smooth market access. 

Labelling Advice

It’s important to make sure that the labels on your products comply with local regulations. This ensures that your products are safe and meet the legal requirements of the countries in which they’re sold. At Rubicon, we offer a professional and reliable labelling advice service to help businesses navigate the complex labelling regulations within the food and food supplement, cosmetics and medical devices sectors

Our expert team has a deep understanding of labelling regulations. We provide tailored advice to help you meet the relevant legal requirements for your product labelling, ensuring that your products are accurately and safely labelled.

Our labelling advice service covers a wide range of topics, including labelling requirements for allergens, ingredients, nutritional information, country of origin, and more. We work closely with your business to understand your specific needs and ensure that your products are compliant with the latest regulations. Read more about our marketing and label checking services.

Nutravigilance

Rubicon’s nutravigilance service is a comprehensive solution for food and dietary supplement companies seeking to ensure the safety and
regulatory compliance of their products. Our team of experts provides ongoing monitoring and risk assessment for adverse events, helping to identify and manage potential safety issues.

Our nutravigilance service is grounded in best practices and expertise, allowing us to provide actionable insights to our clients. We stay up
to date with the latest regulatory requirements and industry standards, ensuring that our clients remain compliant and informed.

At Rubicon, we understand the importance of maintaining customer trust and protecting brand reputation. Our nutravigilance service gives you the confidence to focus on your core business while we manage the details of product safety and regulatory compliance. Read more about our nutravigilance services.

Contact Us:

Need our help? Get in touch today to see which of our services is most suitable for your FBO needs.

Rubicon Technical UK

C4DI @ The Dock, 31-38 Queen Street, Hull, HU1 1UU

Email: info@rubicontechnical.co.uk

Call us: 01482 702726

Rubicon Technical Netherlands

Keizersgracht 555, Amsterdam, 1017 DR,
Netherlands

Email: info@rubicontechnical.nl

Call us: +31 20 3085473