Global Regulatory Affairs

We design and deliver all packaging material and PILs, including any translations that may be required. We guarantee the readability of labels and contents of the PIL by focusing on print size, colour and layout, producing quality product information in all European Union languages.

The labelling services we provide include logo design, barcodes and Braille, as well as assuring that relevant national “Blue Box” requirements are met.

Pharmaceutical Artwork Packaging

  • Folding boxes / Cartons
  • User Testing – Patient information leaflets (PIL) / Instructions for Use (IFU)
  • Summary of Product Characteristics (SmPC)
  • Blister Foils
  • Tubes
  • Adhesive Labels
  • Medical Devices and CE Marking

Artwork For All Stages

  • New pack designs – concepts
  • Product launch artworks
  • Early stage, submission artwork mock–ups
  • Print–ready files

Solid understanding of EU regulations and guidelines

We have a solid understanding of EU labelling requirements and country specific regulations for:

  • Centralised submissions
  • Mutual Recognition submissions
  • Decentralised submissions
  • National submissions
  • * We also implement variations and updates.

Ready-to-Print Artwork

Apart from creating mock-ups, our team could serve as your virtual design team, to ensure that all packaging, PILs, labels, packs and blisters are created and ready for printing.

Multi Language Artwork

We manage multi language artworks for SmPC, PIL and package labelling. We create, review and manage European and National medicinal product labelling for primary and secondary packaging artworks.

Your deadline is our deadline

Our internal processes ensure the timely creation and management of your artwork to meet your internal deadlines for approvals and submissions. We make sure large capacity projects are delivered on time.

Business Cases

Contact Us

If you are interested in our service please contact us for more information.

Telephone+353 125 44033

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