Generic and Originator Pharma

TradeTicity is a member of OPEN-SCS Working Group. OPEN-SCS is committed to define packaging line communication and data exchange standards across the different architecture layers as define by ISA-95 functional levels, thus facilitating the interoperability of different vendor’s solutions.

Can I have 5 different solutions for 5 different markets?

Most commonly manufacturers are operating on international market and their first and biggest challenge is to be legislative in all of their current and also potential markets since every country has adopted its own announced compliance laws. We chose to provide you with a solution that can be used for unlimited number of markets, that can match market specific requirements for each country you do business in. Consequently, you can be operational and legislative in as many markets as you need at the moment but also in the future. 

What can I do if the supply chain doesn’t fit to market requirements?

Many of the manufacturers have outsourced packaging and manufacturing to their CMO’s and packagers. As a manufacturer, you probably have a lot of CMO’s and there is a good chance that your CMO’s have their own CMO’s.  If you want to be in order with pharmaceutical serialization every service provider needs to have established serialization process. In order to do so you have to have a solution which is flexible and integrative both in Typical environment as well as in Heterogenous environments with diversified IT and production equipment urges.

Is your system extendible to supply chain?

Our system enables data enrichment and access to the system for external users, using mobile devices. Those users could be inspectors, government bodies, supply chain partners, etc., It also enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain – from business to business and ultimately to consumers.

You need flexibility and adaptability?

Although EPCIS is commonly regarded as a standard, there are some minor adaptations between different agencies as well as requirements for communication using EDI instead of EPCIS. Thus, the standard EPCIS structure may have to be adapted for: 

  • SFDA – Chinese national drug agency standard, which requires the party to obtain logistic and item numbers from a Central Database 
  • US DSCSA  
  • EU EMVS 
  • Brazil ANVISA agency standard for data exchange  
  • MOH Turkey standard 
  • FSIS MDS in Russia

Our solution can adapt to any standard. We use Integration layer to meet current, but also upcoming legislative requirements. 

Integration with other systems is a problem?

The major task of serialization system is to communicate with external IT systems, different and diverse equipment, national agency systems and repositories; external partners such as MAHs or CMOs, distributors, etc. therefore, CureSync has an adapted Integration layer, able to handle all necessary communication, easily transform and transfer messages between different standards and protocols. This functionality gives a unique advantage, especially for change management, or when it is necessary to agree communication vocabulary between partners and stakeholders.  

CureSync is able to connect to various sources and end points seamlessly, without fear of losing messages or transactions. With embedded message queuing, this represents the ideal solution for integration with production line equipment, using either XML-like schemas, or even drivers. 

TradeTicity is a member of OPEN-SCS Working Group

OPEN-SCS is committed to define packaging line communication and data exchange standards across the different architecture layers as define by ISA-95 functional levels, thus facilitating the interoperability of different vendor’s solutions.

https://opcfoundation.org/open-scs-working-group/

Do you want configurable system, to minimize customization at the programming level?

Often, a simple change in serialization will make any change, e.g. changing the structure of serial numbers from numeric to alphanumeric, or adopting new label structure due to changes in regulation difficult. 

CureSync however, is based on the principle of templating, which enables definition of frames  for almost all entities in CureSync: 

  • Products 
  • Partners (CMOs, MAHs, 3PLs, Distributors, Wholesalers, etc.) 
  • Organizational units 
  • Users of the system 
  • External users (patients) 
  • EPCIS 

Using this approach, CureSync is easily customized to serve different market needs, and is easily adapted for any future change.  

 

Solutions

  • CMO's

    Can you continue your work without serialization solution? Since majority of MAH companies are outsourcing manufacturing to CMO’s you are...

    Read More ...

  • Generic and Originator Pharma

    Can I have 5 different solutions for 5 different markets? Most commonly manufacturers are operating on international market and their...

    Read More ...

  • Marketing Authorization Holder

    What are MAH obligation in regards to Serialization? MAHs are, from perspective of regulatory bodies, only legally recognized entities...

    Read More ...

  • Serialization

    Serialization is applying a traceable serial number to a smallest selling item. A serial number must be assigned to each selling item as...

    Read More ...

  • Supply Chain

    Wholesalers in the whole world are obliged to adapt to different regulations and directives, for example EU FMD – Falsified medicines...

    Read More ...

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Tvrtka: TRADETICITY d.o.o. za usluge / Skraćena tvrtka: TRADETICITY d.o.o. / Sjedište: 10 000 Zagreb, Strojarska cesta 20 / Sud: Trgovački sud u Zagrebu / MBS: 080725073 / OIB: 32457970413 / Temeljni kapital: 3.700.000,00 kuna, uplaćen u cijelosti / Predsjednik uprave: Lidija Pozaić Frketić / Član uprave: Vjekoslav Benussi / Nadzorni odbor: Miodrag Mirčetić, Boštjan Bavdek, Maks Strajher / Osobe ovlaštene za zastupanje: Lidija Pozaić Frketić, Vjekoslav Krešimir Benussi / Banka i broj žiro računa: PRIVREDNA BANKA ZAGREB d.d. Zagreb / IBAN: HR9323400091110426328SWIFT address: PBZG HR 2X / ZAGREBAČKA BANKA d.d. ZAGREB / IBAN: HR9123600001102551948 / SWIFT address: ZABAHR2X