HS061214_SM_2562Labelling content & artwork management leader Kallik’s founder and CEO Neil Gleghorn to present fresh thinking at a major life sciences conference: why now is the time to solve the sector’s content challenges

Tamworth, 9 February, 2015 – Labelling & Artwork management leader Kallik founder and CEO Neil Gleghorn has been invited to deliver a presentation at CSC Life Sciences’ ‘Life Sciences Forum: Innovation for Business Growth’ event.

At the major life sciences conference, scheduled for February 11-12 in Malaga, Spain Gleghorn will present on how the sector can best address the labelling challenges accumulating for players in the industry.

Gleghorn will draw on his extensive knowledge and understanding of the pharma industry’s specific challenges (key to his winning a PharmaVOICE 100 place last year, an award that celebrates the most influential people in the life sciences industry).

Gleghorn will look at typical artwork and labelling practices before outlining the business context: how pharma is battling rising product recalls, to how the medical device field is being forced to respond to latest UDI regulations to how cosmetics firms are tackling new labelling requirements.

This set of circumstances, Gleghorn will argue, means that centralising the creation and management of Labelling and Artwork Management (LAM) needs to be much higher on the C-Suite’s agenda.

For Gleghorn, “The amount of regulation and legislation coming our way has never been higher, forcing the need to have a robust, transparent process in place to deal with this compliance.

“Members of the pharma community need to make labelling a top priority or face major penalties, as well as suffer inefficiencies in their business.”

Kallik has been at the forefront of dealing with these issues, having over a decade helped firms capture and manage labelling-based content digitally so as to transform the way large national and international brands bring products to market.

Gleghorn’s commitment to that vision has helped the UK firm become a truly global player, working with some of the world’s biggest companies in regulated markets including the pharmaceutical, medical device, cosmetics and chemicals vertical sectors.

Gleghorn is available for interview at the Life Sciences Forum on Wednesday February 11 on the need for robust labelling processes: for further information and for interviews, please contact Sarum.

About Kallik

Kallik is a global provider of Labelling & Artwork Management software solutions (LAM) that simplify complex artwork management, generation and approval challenges for regulated industries: Kallik’s systems help these organisations to reduce the risk of product recall, guarantee product and brand consistency, mitigate risk and reduce costs.

Based on technologies using a structured content-centric approach, Kallik’s solutions leverage and repurpose content to automatically generate artwork. This enables businesses to remove duplication, track content and rapidly change messaging to respond to new market and regulatory challenges.

Formed in 2001, Kallik’s founders and senior management team have a rich heritage in the packaging and labelling industry. Its flagship AMS360™ Automated Artwork Management solution was devised based on this insider knowledge of the sector and today underpins the businesses of companies including Sealed Air, Coloplast, Integra, Mary Kay, VitaHealth and Unilever.

More at www.kallik.com, or follow us on Twitter @KallikAMS

PR Contact

Carina Birt

PR for Kallik

carina@sarumpr.com

+44 1722 322916

Kallik has launched a new resource centre for medical device companies having to deal with changes in regulations.

The medical device sector is used to dealing with legislation and meeting tight compliance demands. Nonetheless, it’s currently facing a perfect storm of compliance changes for which manufacturers need to be prepared.

The US Food and Drug Administration (FDA) has now issued a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act. The Year 1 deadline is24 September 2014 and it is expected that similar regulations will follow in Europe and then the Rest of The World.

Kallik’s customers are already addressing these challenges and are sharing their experiences in The Kallik Medical Device & UDI Compliance Resource Centre. The centre includes case studies, news stories, blogs and webinars – all designed to help those affected by the changes understand and navigate through the UDI compliance maze. Bookmark this page and keep checking back for updates.

By Neil Gleghorn, CEO and Founder, Kallik

The last few blogs have been on the topic of making a helpful virtue of a business necessity – that of gearing up for new sector compliance moves that you need to ready for, especially UDI. The aim: use UDI as a spur to improve lots of labeling processes effectively for free at the same time.

Last time we spoke about our Danish client, Coloplast (‘Using Compliance To Your Advantage – 1: Coloplast’). Coloplast says it’s taking UDI compliance to the next level by integrating its Kallik solution with its SAP back-office systems so that it can report on its UDI traceability performance. Another major life sciences company – which prefers not to be named – is even further along in its labelling artwork management initiative.

Based in the US, a world leader in medical devices and implants for use in orthopaedics, neurosurgery, spinal, reconstructive and general surgery, the firm is directly affected by UDI (which is set for go-live in September). To give you an idea of the kinds of labeling issues that can land on their desks, in one of its manufacturing sites it recently needed to make 10,000 changes to labelling artwork.

Before Kallik’s AMS360 came along, that’s a process that would have involved at least 90 weeks of work – all in loops of new artworks being developed, amended, re-approved, changed – and eventually getting signed off.

But by investing in a centralised content management and integrated artwork generation and system from us, the company has not only prepared for UDI but in the latest application involving 10,000 artworks got that 90 weeks down to just 10 days.

This is resulting in cost savings that could run into millions for this company alone.

Plus, the firm is also able to get its products to market much earlier – safe in the knowledge that all labelling is fully compliant with UDI and other regulatory changes (e.g. involving safety symbols used on labels).

“Kallik allows us to manage all changes and approvals centrally, in a single location,” explains the company.

“Everyone works on the same, latest version of the content, rather than a series of emails that have been sent back and forth. In terms of compliance control, our use of Kallik AMS is about managing label content across the organisation – so that we can change a symbol very quickly as these are updated, and understand where patent numbers are located as these expire.”

Sounds impressive – and it is. This is a really outstanding example of using technology for business advantage – as well as tying off the whole UDI/compliance issue.

I will finish this run of blogs with just one more next time – an example of a German firm that has done something equally significant.