Market knowledge gives us an advantage
that we can give to you.

It provides us with information about relevant regulation & compliance issues: regionally, nationally and globally.

If you are embarking on a track & trace or authentication project in the
near future, you should ask yourself:

• What Changes in legislation and regulation are planned
  or happening today. Where, when, how?
• How will planned changes affect your business
  now and in the future. Do you have a strategy?
• Will these changes mean radical alterations to your future plans
  or can you handle them with your existing structure?

Over recent years much of the pharmaceutical and healthcare industry
has been on alert to possible changes in track and trace compliance in a number of regions of the world.

In the US there have been a number of false dawns as to when e-Pedigree solutions were due to implemented; only to be delayed.  The latest news is
that 2015 will be the next key date when California is planning to start using
a full e-Pedigree solution.

But can the U.S. wait that long? And what about Europe?

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But can the US wait that long?

Are the recently announced, “FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States” with its 2-year window and the, “FDA - Guidance for Industry - Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages - Draft Guidance”
- that is due for implementation by March 2010, really going to sit on the shelf
4 or 5 years while the rest of the world implements, learns, develops systems and improves patient safety an supply chain efficiency – We think not?

What about Europe?

In Europe the EU is still mulling over its stance and taking soundings though
the highly successful EU funded Bridge Project www.bridgecasestudy.com
on which a number of the MENTOR team worked – nears completion.

EFPIA, France, IFAH and Turkey are moving forward with pilots and full implementation – even though the French CIP system is only at product level rather than unique item level – at this stage. IFAH have already taken the first successful steps into Mass Serialisation to a similar level as France but now also shows signs of moving towards unique item level Track & Trace.

EFPIA is about to announce its first full pilot to test its infrastructure model in
a single European country – rumours of a Northern European destination abound. The this will replicate much of the coding, marking, aggregation, technology use and code structure as the EU Bridge Project – again not surprising that a number of those connected to Mentor have been involved
in its design and development.

Turkey however, offers the potential to create a really original model implementation based on reducing reimbursement fraud as well as counterfeiting. If this model really works, again much of it based on the Irish Blood Trial and the EU Bridge Pilot – both Mentor team influenced – will all the governments across Europe, America and the Far East really wait years to implement if major savings and benefits can be gained. All of these based on simply marking and coding item level cartons or packs with some aggregation and data input and storage.

But what about the future, what about identification of medication at dose not just dispense level? What about the issue of re-packing and the loss of traceability that this practice, though legal, causes?

The team at Mentor have built, tested, demonstrated and validated a complete retro-fitted production line down to blister pouch – each tablet or capsule – in addition to blister strip, bundle, multi-pack, patient safety leaflets in addition to carton, case and pallet. We still believe nobody else has done this, has made it work or has validated to GAMP. FDA and ISO standards so we truly know what to do and how to do it.

Our approach is to create a truly workable step-by-step plan for all of our individual customers - to firstly understand the level of knowledge and expertise that organisations hold today. Secondly to look at their plans for the future
– no matter how vague or conceptual – and develop a detailed map of how to
get from today’s position to a fully implemented track & trace mass serialization solution.