Our Regulatory Services

We can help

Rubicon Technical’s regulatory services provide businesses with the expertise and support needed to navigate the complex world of regulations and compliance. We understand that staying compliant with government and industry regulations is crucial for the success of any businesses, but it can also be time-consuming and overwhelming task.

With our team of experienced professionals, we offer a variety of services aimed at helping businesses stay on top of their regulatory requirements.

We can help with:

New Product Registrations (Product Licences, ASMFs)

Rubicon Technical Ltd can provide the complete end-to-end support for new product registrations.  Our team of consultants have a wealth of experience of the various registration processes for different product types to enable you to meet the complex requirements of the various regulatory authorities, in a timely manner.

Our specialist team can support with the following:  

  •       Medicinal Products
  •       Traditional Herbal Medicines
  •           Medical Devices
  •       Homeopathic products
  •       Food supplement registration
  •       Cosmetics


eCTD Validation, Publication and Submission

We can undertake eCTD validation and publication for all your regulatory submissions, using an advanced electronic submission management system. Furthermore, we can manage the submission of the eCTD to regulatory authorities for review and approval.  Out-sourcing eCTD publishing is a cost-effective approach that many companies utilise to avoid having to purchase their own publishing software and train employees.      

Readability Studies and Bridging Reports

Ensure that your patient information leaflets are legible, clear and easy to use with a comprehensive readability study. Rubicon Technical Ltd can design and undertake the study to produce a report which will meet the requirements of the European Commission. We can also author Bridging reports to link an existing readability study to a patient information leaflet with the same template.

Lifecycle Management Activities – Variations and Notifications

The importance of a solid lifecycle management strategy has been long acknowledged as a key aspect to ensuring compliance.  Our services cover every aspect of lifecycle management from the initial notification of the product to Variations throughout the lifecycle.  We can prepare all the necessary documentation to create the submission package to meet the regulatory requirements of the receiving authority.  

Regulatory Strategy : Maximising Regulatory Opportunities

Our experienced consultants can collaborate with your team to create concepts and develop proposals to help your business maximise regulatory opportunities.  Superior regulatory strategy ensures your business is staying ahead of the field.

Regulatory Compliance from Gap Assessment to Remediation

At Rubicon Technical Ltd, we understand that there can be times when a company falls behind with regulatory compliance due to various
reasons.  Alternatively, you may have an inspection looming and want added assurance that everything is in place.

Our services can identify and evaluate the gaps in regulatory documentation and system to create a comprehensive gap assessment report.  Following on from this, we can develop a remediation programme and provide external resource to bring the business back effectively and efficiently into compliance.  

Export Market Registrations

Our consultants can undertake export market registrations in local language in all EU countries and the Rest of World.  We understand the unique requirements of each market for successful registration in a timely manner.  If you’re looking to expand your market access, speak to us and find out how we can assist you.


These are just a few of the services we can provide for your regulatory needs, get in touch with us today.

Contact Us:

Need our help? Get in touch today to see which of our services is most suitable for your regulatory 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,

Email: info@rubicontechnical.nl

Call us: +31 20 3085473