France-based Adents has made a name for itself in the European serialization sector and now the company has brought its expertise to North America.

Headquartered in Paris, Adents provides serialization and track-and-trace software solutions for the pharmaceutical and life sciences industries. Founded in 2007, the company just recently opened its first U.S. location in Princeton, NJ, right on the heels of debuting its first North American subsidiary in Montreal, Canada. By the end of 2015, the company expects to have approximately 50 North American personnel.

Entrance into the U.S. market was a logical next step particularly in light of the pending, potentially rolling implementation of 2013’s Drug Supply Chain Security Act.

Adents’ senior director of sales for the Americas, Erik Bronander, talked with Contract Pharma about serialization trends and how Adents is helping its customers meet the challenges of drug traceability regulations. Below is a portion of that talk. The full interview will appear in the upcoming September issue of Contract Pharma.

Contract Pharma: What are the top questions you receive from pharma companies and CMOs who are beginning their serialization preparation and/or implementation?

Erik Bronander: “What do I need to do?” is clearly number one. Especially in the CMO/CPO space where so much of it depends on their customers. Of course, there are a host of follow-up questions to this, including, “Who is generating the serial numbers?” “In what format?,” “Do you aggregate right away?,” and “What data gets transferred and when?”

Second is, “How much will this cost?” which truly needs to be evaluated by the total cost of the implementation, not simply the upfront equipment or license cost, as these are mission-critical systems that will require changes as regulations and products change.

The third and perhaps most undervalued is, “How long will this implementation take?” Here, there is not just the timeframe for a system implementation to be considered, but all of the tangential items that will be required. Understanding the possible downtime to a production line has made more than one client change their mind from upgrading something to a complete replacement due to the reduced impact to production.

CP: What are the regulatory changes from point of manufacture throughout the distribution chain? What’s coming down the line?

EB: First is the data exchange requirements of Transaction Statement, Transaction Information, and Transaction History. This was put in place this year and while the data exchange method is very liberal for the first 2 years, the storage and retrieval on demand requirements complicate this. The item serialization requirements for 11/27/2017 will not affect that from a TS/TI/TH perspective yet.

While full aggregation and data exchange of that information is not required for a number of years beyond 2017, there is a very strong likelihood that many major supply chain participants will require it sooner and most likely enforce that through additional costs.

The largest area of change will be in the area or reverse logistics. Currently it is a complete disaster for manufactures and the large distributors as well. Item level serialization provides the mechanism to discern if a product is authentic, legitimate for return, being returned compliant to the supply chain network constraints (e.g. was that product available though that returning partner), and for many manufacturers being cr

CP: How can Adents’ software help pharma companies and their service providers?

EB: Adents device independent serialization software provides the least disruptive path to serialization implementation for pharma companies to reach compliance. Our software-based approach is perfectly aligned with service providers’ business models.

Developed in compliance with GMP and 21 CFR Part 11 regulations and following GAMP5 guidelines, Adents’ serialization software solutions perform a variety of crucial track-and-trace capabilities, including: generation of unique barcodes and importation of serial numbers; affiliations management for origin identification—bundle, pallet, etc.—and distribution of various types of serialized code; facilitate and drive the printing of unit barcodes, and control their conformity; and data centralization and reports processing.

Adents Pharma Suite utilizes user-friendly, standardized turnkey software compatible with both information systems—ERP, MES—and existing production and packaging equipment. Easily upgradable, the software is designed to address both current and emerging regulations to help pharma companies remain in compliance long-term.

The Adents Pharma Suite software has several key differentiating attributes, including speed to deployment, with an implementation up to five times faster than competing serialization solutions; easy configuration, consisting of plug-and-play modularity for existing hardware; cost-effectiveness, as evidenced by a cost of less than $100,000 per line, service included; and maximum flexibility with easy, centralized changeovers.

For more information visit Adents on the web here.