rfxcel Enhances Pharmaceutical Track and Trace Solution for Russia

Pharmaceutical Track and Trace Solution for Russia, August 16, 2018:  rfxcel, the global leader in track and trace solutions, releases enhancements to its compliance solution for Russia and kicks off additional customer implementations in the Russian marketplace.

Russia compliance is now fully embedded in rfxcel’s Compliance Management (rCM) and Serialization Processing (rSP) modules. The extended Russia support builds upon rfxcel’s awarding winning Traceability System (rTS) and continues rfxcel’s long-standing commitment to help customers meet global compliance needs.

rfxcel is actively rolling out its Russia compliance solution for pharmaceutical customers to meet the serialization, aggregation, traceability, and reporting requirements for the Russian market.  As one of the first compliance providers to implement for Russia, rfxcel is strategically positioned to help pharmaceutical companies achieve compliance well in advance of the January 1, 2020 deadline mandated by the Russian government.

Russia’s Federal law 425-FZ requires medicines to be uniquely identified across packing levels with additional Russia-specific cryptography.  Under Russia’s Federal law, participants must track and report products in various stages of the supply chain.  This information is reported to Russia’s centralized Federal State Information System for Monitoring Drug Circulation (FSIS MDC).

“We are extremely proud to work with our customers to meet Russia’s compliance regulations – arguably the most complex in the world.  Delivering a serialization, aggregation and reporting solution for compliance requires not only robust software, but also demands an experienced local and international team with the skills and flexibility to manage an end-to-end project.  rfxcel offers both the solution and service to ensure success,” said Mark Davison, Senior Operations Director, Europe.

Many pharmaceutical companies are challenged in providing resources to meet and deliver a fully validated compliance solution.  The rfxcel implementation team consists of both global and local Russian resources who provide a full-service experience.  This approach is extremely well received by our customers and allows them to shift the worry of compliance to rfxcel so they can focus on their core business.

 

About rfxcel

rfxcel is a leading-edge track and trace solution to help companies meet regulatory compliance requirements, protect their products, and brand reputation. rfxcel has been an industry leader since 2003, expanding to locations beyond the US to include the EU, Russia, India, Brazil, and APAC. rfxcel’s unique integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

To learn more about rfxcel or participate in rfxcel’s Russia compliance program please contact us at https://www.rfxcel.com/contact-rfxcel/.

 

Herb Wong

Head of Marketing

hwong@rfxcel.com

(925) 824-0300

Turkish Pharmaceutical Industry leader, Abdi Ibrahim, selects rfxcel for FMD compliance

August 2, 2018: Abdi Ibrahim, the Turkish pharmaceutical industry leader, has carefully selected rfxcel to implement and support new compliance management and serialisation processing software to ensure full compliance with current and future international legislative requirements ahead of the 2019 EU Falsified Medicines Directive (FMD) deadline.

 

Abdi Ibrahim, founded in 1912, began as a small pharmacy that has since grown into the leader of Turkey’s pharmaceutical industry, holding the largest product portfolio within the sector and operating in 10 countries outside of Turkey. Today, Abdi Ibrahim’s portfolio exceeds 180 brands and more than 350 products which it exports to 50 countries ranging from Canada to the European Union member states, from North Africa to Asia.

 

With the February 2019 FMD deadline fast approaching, Abdi Ibrahim needed a solutions provider that would enable them to become compliant in time for the FMD deadline, but additionally would fulfil their need for new, modern technological operations with data integrity at their core.

 

After an in depth review, analysing several industry products and providers, Adbi Ibrahim selected rfxcel due to the solution’s rich functionality as well as the company’s Single Tenant private cloud deployment, its full-service implementation methodology, flexibility and speed and competitive pricing.

 

Rumeysa Tanrikulu, Information Systems Supervisor at Abdi Ibrahim explains, “It was really important for us to implement a software solution that was single-tenant rather than multi-tenant. rfxcel was one of the only single tenant providers that offered a bespoke service at a reasonable cost. What’s more, the team at rfxcel was direct, clear and extremely helpful, answering all the questions we threw at them.”

 

She adds, “The team was friendly and driven not by the sale, but by the benefit they could bring to the business. For us, given the weight of responsibility we feel we carry in improving the health of the population we serve, their company ethos was very much aligned to ours. So far, our relationship has been honest, collaborative and we have full visibility of the implementation process that will help ensure not only regulatory compliance, but a future-proof supply chain that is built upon the foundation of data quality.”

 

Adbi Ibrahim is currently mid-implementation with aims for the compliance management and serialisation processing software to be live during October 2018.

 

About rfxcel

rfxcel is a supply chain track and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.

Find more information about how rfxcel is shaping the future of supply chain at https://www.rfxcel.com

 

Herb Wong

Head of Marketing

Hwong@rfxcel.com

(925) 824-0300

rfxcel VRS (Verification Router Service) Pilot Open to All Supply Chain Partners

July 31, 2018:  rfxcel, the global leader in track and trace solutions, announces the start of rfxcel VRS Pilot, which is now open to all pharmaceutical trading partners.  This is a major step in helping organizations meet the U.S. Drug Supply Chain Security Act (DSCSA) requirement for Saleable Returns.

rfxcel is already working with VRS participants from the “Big Three” wholesalers, manufacturers, repackagers, national/regional pharmacies and dispensers.  To support the readiness of the industry, rfxcel is taking the next step and is extending its VRS pilot to all DSCSA stakeholders.

“This is a significant commitment from rfxcel to meet a critical need in the pharmaceutical industry.  VRS is important to the success of DSCSA.  We realize that there are many who need to evaluate the readiness of their organization.  To facilitate this, rfxcel is taking an unprecedented step and opening up our VRS Pilot to all trading partners,” said Atul Mohidekar, Chief Technology Officer of rfxcel.

VRS is an industry initiative sponsored by the Healthcare Distribution Alliance (HDA). It allows pharmaceutical supply chain partners to quickly exchange data and verify the validity of a product being returned for sale.  The end goal of this effort is to ensure the authenticity of products and the safety of patients and consumers.

rfxcel VRS effort will support both Requestor and Responder scenarios to ensure end-to-end compliance. Using the Responder functionality, manufacturers and repackagers will be able to respond to verification requests. Distributors will be able to use the Requester functionality to verify authenticity of the resalable products.  A key requirement of VRS is the support for a Lookup Directory (LD), which enables quick delegation of requests to the proper owners. rfxcel will provide the LD functionality to facilitate routing of product authentication requests. rfxcel will also provide an option to use blockchain-based VRS and the LD solution to align itself with industry initiatives. With the combination of VRS, LD, Responder and Requester capabilities, rfxcel will be able to provide the full spectrum of verification functionality to manufacturers, repackagers and distributors to comply with the DSCSA law.

“rfxcel has always supported an open partner ecosystem.  We are committed to working with HDA, our customers and other pharmaceutical trading partners to help secure the supply chain.  This effort will save lives and it is imperative to have this in place for patients and consumers.  Opening up rfxcel VRS Pilot to the industry will help to accelerate this process,” said Glenn Abood, Chief Executive Officer of rfxcel.

 

To learn more about rfxcel  or participate in rfxcel VRS pilot please contact us at Contact Us.

 

About rfxcel

rfxcel is a supply chain track and trace company. rfxcel provides leading-edge track and trace solutions to help companies meet regulatory compliance requirements, protect their products, and brand reputation. rfxcel has been an industry leader since 2003, expanding to locations beyond the US to include the EU, India, Brazil, and Japan. rfxcel’s unique integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

 

rfxcel vrs

Walmart EVP and Amgen SVP Join rfxcel’s Board of Directors

SAN RAMON, CA,  July 18th, 2018 – rfxcel, leading track and trace software provider, announced today that Chris Sultemeier, formerly from Walmart, and Martin Van Trieste, formerly from Amgen, have joined rfxcel’s Board of Directors.

Chris Sultemeier brings over 30 years of leadership experience in supply chain operations to the rfxcel organization.  Chris was the Executive Vice President of Logistics at Walmart, as well as the President and CEO of Walmart Transportation LLC. During his tenure, he was responsible for all domestic and global distribution and fulfillment.  Chris received the prestigious Sam M. Walton Entrepreneur of the Year Award for his efforts on sustainability. Chris also serves as an instructor at MIT’s (Massachusetts Institute of Technology) Master’s Degree program for Supply Chain/Logistics/Transportation.

“I spent a life time working to improve supply chain efficiency; working with the industry leader, Walmart, I was fortunate to spearhead many new innovations which have now become common place.” says, Chris Sultemeier.  “I look forward to bringing this experience to a new leader, rfxcel, who will bring improved visibility and control to the supply chain across a wide-range of industries.”

“Chris’s expansive knowledge of supply chain tracking and optimization, combined with rfxcel’s world-class traceability platform will bring new business value to many organizations.  Chris’s vision and enthusiasm for transforming the supply chain is infectious and I am excited to welcome him to the rfxcel’s Board of Directors.”, says Glenn Abood, CEO.

Also joining the rfxcel board is Martin Van Trieste.  He is currently the Immediate Past Chair of the Parenteral Drug Association (PDA) which is committed to developing scientifically sound, practical technical information, and expertise to advance pharmaceutical and biopharmaceutical manufacturing science and regulation so members can better serve patients.

Martin’s experience includes serving as Chief Quality Officer and SVP of Quality at Amgen, as well as VP of Quality at a number of large biopharmaceutical companies. Martin’s decades of experience provide rfxcel with a varied and comprehensive knowledge of the industry.

“I am excited to join rfxcel in its mission to provide serialization, and track and trace technology to protect patients and consumers.  As a former SVP of Quality, I was drawn to rfxcel because of its commitment to quality.  rfxcel’s solution provides the most extensive verification of data in the industry. This commitment to quality data is essential to protecting consumers and the supply chain.”

“rfxcel has had the privilege of working with Martin over a number of years.  He has demonstrated the capacity to think strategically and deliver tactically.  We look forward to the new insights and leadership that Martin will bring to the rfxcel’s Board of Directors.”  said Glenn Abood, CEO.

 

For more information about rfxcel’s Board of Directors:

Herb Wong, VP of Marketing

hwong@rfxcel.com

www.rfxcel.com

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

Walmart, rfxce'sl Board of directors

Triple digit growth in EMEA as pharma companies embrace rfxcel’s full-service approach to FMD compliance

June 15, 2018 – San Ramon, CA – International provider of SaaS-based track and trace and serialisation solutions, rfxcel, today announces its continued successful expansion in the UK and EMEA, with triple digit percentage revenue growth since 2017. Increasing numbers of pharmaceutical companies welcome rfxcel’s inclusive approach to helping its clients successfully achieve the EMVO (European Medicines Verification Organisation) onboarding process as part of their compliance with the Falsified Medicines Directive (FMD).

rfxcel now boasts on-the-ground sales, delivery and customer support teams across four continents, including its US headquarters, an EMEA head office in the UK, and bases in Latin America, India and Japan as well as local capability in Russia. Sales headcount has increased by 300% and delivery and support teams by 350% over the same period. Working relationships with major global business partners have also been established, further extending rfxcel’s complementary offerings.

Mark Davison, rfxcel Senior Director of Operations Europe, comments: “rfxcel prides itself on our rapid, full-service implementation model, which provides a great opportunity to marketing authorisation holders (MAHs) who need move quickly.  With the February 2019 FMD deadline rapidly approaching, companies are recognising that they need an experienced provider who can not only support them through the initial implementation but will go the extra mile to ensure the success of their solution, from data integrity to testing the end-to-end connectivity, reporting and interaction with business partners. Many customers have already registered rfxcel as their EMVO provider.  With our established links to the European Medicines Verification System (EMVS) for MAHs, as well as national systems (NMVSs) for distributors and dispensers, we provide an award-winning solution for the whole supply chain impacted by FMD.”

Mark Davison further comments: “As an additional benefit, rfxcel’s full-service implementation model, enables companies to also avoid the hidden costs and additional resources required by other solution providers to onboard their trading partners.”

Glenn Abood, Chairman and CEO, rfxcel, adds: “Patient safety is at risk if people can’t verify the validity of the drug. rfxcel’s aim is to help the global pharmaceutical industry mitigate that risk and protect their patients and products. With integrity at the heart of our business – from helping clients with their data integrity, to our commitment to our customers – we help secure the supply chain, bring visibility in product distribution, enable compliance with government regulations, and ensure patient safety. We are immensely proud that this is an ethos that is being recognised and welcomed by the industry.”

On 20th June 2018, rfxcel is hosting a webinar entitled: ‘The EU Falsified Medicines Directive: Data Integrity in a Serialised World’, covering aspects of FMD compliance including why data integrity is only as good as the weakest link; how data errors can occur in validated systems; why active error checking is needed; what the regulators are planning; and how organisations can prepare.

For more information or to learn more about the requirements surrounding the European Union’s Falsified Medicines Directive (FMD) or rfxcel’s solutions to meet these needs, please contact us.

rfxcel Covers the Cost of EMVO On-boarding Fees

May 23, 2018 – San Ramon, CA – rfxcel Corporation, a technically certified Gateway Provider for the European Medicines Verification Organisation (EMVO) announced today that it will pay the cost of statutory fees payable to EMVO* for all manufacturers (Marketing Authorisation Holders, MAHs) which select rfxcel as their Gateway Provider before June 15th 2018.

Manufacturers who wish to participate in this great opportunity should contact rfxcel (eu@rfxcel.com) for details of the solution and terms of the offer. They then simply need to name rfxcel as their Gateway Provider when registering on the EMVO portal (https://emvo-medicines.eu/pharmaceutical-companies) before June 15th 2018. When we conclude a software contract, the cost of the EMVO fee will be absorbed by rfxcel as a discount.

With EMVO onboarding fees increasing by 50% after June 15th 2018, rfxcel is taking a significant step in helping EMVO to accelerate its onboarding programme and MAHs to meet their requirements under the Falsified Medicines Directive in a timely manner.

rfxcel provides a full-service, fixed price approach that gets MAHs ready to exchange data with EMVO quickly and efficiently. We manage the end to end process from EMVO onboarding to connection, reporting and interaction with business partners such as contract manufacturers (CMOs). This enables even very small MAH companies to comply with FMD obligations with minimum resource and cost impact.

“Our initiative to cover the cost of the EMVO onboarding fee, paired with our rapid, full-service implementation, provides a great opportunity to MAHs who need move quickly.  With rfxcel they also avoid the hidden costs and additional resources required by other solution providers to onboard their trading partners”, said Mark Davison, rfxcel Senior Director of Operations Europe.

To learn more about the requirements surrounding the European Union’s Falsified Medicines Directive (FMD) or rfxcel’s solutions to meet these needs, please contact us.

*The offer relates to EMVO (one-time) onboarding fees only. It does not include any initial or annual fees that may be payable to national medicine verification organisations (NMVOs).

For more information contact us:

Herb Wong, VP Marketing

hwong@rfxcel.com

rfxcel.com

 

rfxcel Drives LATAM Expansion

rfxcel announced today that they will expand their capability to enable LATAM Life Science(s) organizations to meet serialization and regulatory compliance requirements throughout Latin America and around the globe.

rfxcel is excited to announce the addition of Vinicius (Vinnie) Bagnarolli to their growing team of industry experts. Vinnie will be serving as the Commercial Director for Latin America. He will be responsible for driving rfxcel’s overall sales strategy and offerings to both existing and new clients throughout the region.

Vinnie joins rfxcel with an impressive resume; he has played leading roles with organizations such as Dell and Oracle. Prior to studying International Business Management in Canada, Vinnie managed a “technology stack” (Database, Middleware and Business Intelligence) division in São Paulo, Brazil that served both the Health Care and Life Sciences industries. Vinnie credits his success to his belief in educating both himself and his customers to be a reference in the industry. Most recently, he managed a Healthcare Global Business Unit and reported directly to the VP of Sales at Oracle’s headquarters in Redwood City, CA.

“rfxcel’s mission is a great fit for Latin America” says Vinnie. “We need companies that want to thrive and who want to help people – rfxcel’s expansion into LATAM and around the globe is making a positive impact on society.” Vinnie went on to say “Being part of an organization that puts their customers first and helps ensure products are safer and free from counterfeits is something that I am proud to be a part of.”

As the pioneer and a leader of track and trace solutions for the Life Sciences industry, rfxcel provides a robust product platform as well as a full-service implementation/support model, that ensures customer success, patient safety and peace of mind. rfxcel would like to officially welcome Vinnie to the Team, and we look forward to the opportunity to help fulfill the serialization and compliance needs throughout Latin American countries.

 

 

rfxcel launches fully integrated Warehouse Edge System with partner Navitas Life Sciences

rfxcel Corporation, the global serialization and track and trace provider for the Life Sciences industry, announced today that its industry-leading traceability system now has fully integrated “edge” functionality for warehouse, distribution and re-work operations (Warehouse Edge System).

rfxcel has extended its successful partnership with Navitas Life Sciences (“Navitas”) to provide a seamless and efficient solution to enable customers to meet obligations under the European Falsified Medicines Directive (EU FMD), US Drug Supply Chain Security Act (DSCSA) and other serialization requirements. The advanced and simple-to-use features of the Navitas traceREADY edge system are now completely integrated with rfxcel’s Traceability System (rTS).

“The new capability provides a truly full-service, one-stop capability for distributors, manufacturers, and the many companies who have a complex hybrid of both operations. Edge and re-work activities during manufacturing and supply can now be handled directly and smoothly in our system. As global regulations increasingly affect distribution as well as manufacture of medicines, we are positioned to offer what customers need” said Glenn Abood, CEO of rfxcel.

“We are pleased to strengthen our successful relationship with rfxcel. Our fully integrated solution now provides customers with significant cost and performance efficiencies. We look forward to taking our solution to the global market and deliver enhanced value to our customers” said Ram Yeleswarapu, President, Navitas Life Sciences.

In the complex world of traceability, rfxcel is refreshingly easy to work with. Transparent pricing and robust private cloud architecture allows customers to get compliant quickly and at predictable cost. They can then focus on their core business without the constant risk assessment and revalidation required by some providers.

Learn more about Serialisation/Serialization and their edge system by booking a 30 min demo with the IT team.

rfxcel Solution Recognized in HDA Distribution Management Award

March 6, 2018 – San Ramon, CA – rfxcel, the world’s leader in supply chain track and trace for the Pharmaceutical industry is one of two companies recognized by the HDA (Healthcare Distribution Alliance) for “…:efforts to improve the efficiency, effectiveness and safety of the healthcare supply chain through successful trading partner initiatives.”

“The award highlights innovative collaborations between distributors and manufacturers that enhance processes, reduce costs and leverage advanced technologies or logistical practices. Recipients are models for leadership and innovation in the pharmaceutical distribution industry and demonstrate the power of successful trading partner relationships .“ HDA Distribution Management Award

rfxcel’s Environmental Monitoring (EM) solution, was awarded Merit Finalist by the HDA for our work to enable real-time visibility of the Pharmaceutical supply chain via IOT (Internet of Things) technology.  The EM solution was piloted with a global manufacturer to track high-value pharmaceutical shipments – delivering real-time location and temperature data across 24 domestic and international locations.

“We at rfxcel are extremely excited about this award from the HDA.  It is recognition not only of our innovation but our commitment to partnering with the HDA and other industry leaders.” said, Glenn Abood, CEO of rfxcel.  

During the pilot, the rfxcel EM solution identified temperature excursions in real-time and alerted the manufacturer to these risks.  This allowed the manufacturer to take immediate action with their logistics provider and protect the integrity of their products. The solution also identified shipments which were improperly delivered to holding locations that were not approved to handle the products.  These improper deliveries were corrected in real-time avoiding potential damage to the high-value products.

“Today, many pharmaceutical companies are focused on meeting near-term serialization and compliance requirements such as Europe’s FMD (Falsified Medicines Directive), United State’s DSCSA (Drug Supply Chain Security Act), and many other governmental requirements. Our EM solution allows companies to extend the value of their compliance and serialization investment to gain new business value that was previously unavailable. Many companies talk about ‘Value Beyond Compliance’ but today, we have demonstrated that we can deliver on this commitment.” said Jack Tarkoff, Chief Strategy Officer of rfxcel.

As the pioneer and leader in traceability solutions for the Life Sciences industry, rfxcel provides its customers with a robust and sophisticated platform with a low total-cost-of-ownership. The EMVO certification – combined with a recent $30M growth capital infusion, the acquisition of Frequentz assets, and important key hires in Europe – widens the Company’s lead as the most versatile player in the industry.

To learn more about the HDA Distribution Management Award, visit:https://www.hda.org/about/industry-recognition/dma

If you would like to receive more details or see a demo of rfxcel’s Environmental Monitoring (EM) solution, please contact us at: https://www.rfxcel.com/contact-rfxcel/

 

For more information contact us:

Herb Wong, VP Marketing

hwong@rfxcel.com

rfxcel.com

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

To learn more here: Serialization Software

HDA.Award.rfxcel.traceability