Hundreds or thousands of SKUs cannot be managed like dozens of SKUs are
We must separate the need for creation from the need to extend, manage and control all graphic designs in the presence of multipliers: multiple languages, regulatory requirements in various markets, primary and secondary packaging artworks…
In the light of European Union’s (EU) Falsified Medicines (FMD) Directive 2011/62/EU that mandates serialization and tamper evidence safety measures in all prescription medicines, Lacía Health generates ad-hoc projects to review and modify artworks for the complete portfolio of our cients in the pharmaceutical industry.
We identify a different solution when packaging design need involves two variables:
Solucion = large volume + time constraints.
Time is of essence in projects and deadlines must be met.
Hundreds or thousands of SKUs cannot be managed like dozens of SKUs are.
The Capacity to manage large volumes of artwork needs a design team with the appropriate tools and method to adapt to client demands.
The need for coordination and control are drastically different in such scenarios, all touchpoints must be connected.
Creating and coordinating large scale artwork projects for pharmaceutical products in multiple languages, whilst ensuring labelling quality requires a specialist. We specialise in the creation and management of EU and Local medicinal product labelling for primary and secondary packaging artworks.
Our experience covers creating, reviewing and management of multi-language packaging for Patient Information Leaflets (PIL), SmPC, blisters, labels, cartons, and more complex packaging for medicinal products such as; medical devices, kits, applicators, delivery devices and more...
When it comes to your technical review and internal project sign–off with Headquarters and internal stakeholders (e.g. Medical, Regulatory, Marketing) – Lacía Health can provide assistance in the form of compliance and labelling presentation material (dummies, mock-ups…).
Our internal processes ensure the timely creation and management of EU pharmaceutical labelling which meets your internal deadlines for approvals and EMA filing deadline submissions. We make sure large capacity projects are delivered on time.
Lacía Health maintains a solid understanding of EU labelling and ‘Bluebox’ requirements and country specific regulations for; Centralised, Mutual Recognition/Decentralised and National marketing authorisations. Our multi language artwork experience means we also implement variations and updates correctly.
If your medicinal product was originally registered in another region, for example; Japan or the United States - we can assist you with adapting the branding and design for your EMA submission and make it compliant. And at the same time, we can ensure the new branding design complies with your corporate standards.