Obelis Group

Activities: Regulatory

Obelis Group is a leading specialist in European regulatory, directive, and compliance strategy. Its responsible person and consultancy services have helped thousands manufacturers introduce products successfully to the EU market. Founded in 1998, the Obelis Group operates as one of the largest regulatory and compliance centers in Europe. Obelis Experts provide the most effective processes for helping our clients achieve what’s necessary to sell and maintain their products on the European market. Located within walking distance of the EU Headquarters in Brussels, we are an active member of the European Commission working groups to ensure our clients are represented and up to date with the latest piece of legislation

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Obelis Group

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We register your cosmetic products in Europe in 8 working days!

As your EU Consultant, Obelis will:

  • Become your EU Responsible Person
  • Perform formulation review
  • Compile your Product Information File (PIF)
  • Conduct Labelling Review
  • Validate your Claims
  • Secure your Safety Assessment
  • Complete your CPNP Notification
  • Support your UK compliance.

Appoint Obelis as your EU Responsible Person at www.obelis.net

Download our free guidance on Compiling a Product Information File here (PIF)!

Get the Cosmetic Regulation 1223/ 2009 Labelling Guidance available here!

Food Supplements

We help Food Supplements manufacturers register their products in Europe! Our main services include: Food Supplement Information File Template (FSIF) compilation, labelling revision and translation, pre-market registration.

Download our brochure here to learn the 4 steps to EU compliance!

Download our FSIF free template here!

Obelis’ activity in the European cosmetics industry runs deep, allowing it to offer quality European responsible person services including: file verification, testing guidance, labelling review, product market notification, cosmeto-vigilance, market updates and consultancy, claim research and validation, nano-material notification, sales certification, and team training on key compliance.

Our services include (but are not limited to):

EU Responsible Person

Guiding you through the appropriate compliance pathway and thus ensuring a smooth EU Market penetration while also safeguarding continued success in an ever-changing marketplace.

EU Product Registration / Pre-Market Notification in the CPNP

One of the main requirements of the Regulation EC 1223/2009.

Technical Documentation Review and Submission

Can be referred to as a number of names—technical file, EU documentation, EU dossier, Product Information File, Product Information Packet and more.

EU Consultancy and Training

Are you a non-EU based manufacturer looking to successfully navigate the complexities of the EU Market and want to lean on a professional in order to remain focused on sales and business development?

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At Obelis, we specialize in ensuring regulatory compliance for Cosmetics, Medical Devices and other industries. Our Responsible Person and Authorized Representative services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US, Switzerland, Canada, Türkiye and beyond to support your compliance needs effectively
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