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Interview with the Winner of the 4^th Central Eastern European (CEE) Pharmaceutical Manufacturing Excellence Award! 

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In 2018 at PHARM Connect SoftGroup together with their client Tchaikapharma from Bulgaria won the 4^th CEE Pharmaceutical Manufacturing Excellence Award in the solution provider category by developing a Serialisation and Track & Trace (SaTT) solution for the pharmaceutical industry to comply and cover the requirements of the European Union’s Falsified Medicines Directive.

We interviewed Venelin Dimitrov the founder and CEO of SoftGroup to learn more about the winning project. He has always considered himself as a problem solver from an early age. Naturally interested in computer science and electronics, he passionately studied IT as a part of his MSc degree at the University in Veliko Tarnovo, Bulgaria. Shortly after graduating, he started his career as a software engineer. He had the strong motivation and persistence to use his talents to innovate, which helped him to create a successful business.

SoftGroup is an innovative software company with over 15 years of experience in developing their own systems, with an emphasis on the field of pharmaceutical Serialization and Track & Trace solutions. The company offers a complete solution with software, hardware, and all the related services and support.

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  Which solutions and improvements did you introduce for your client?

Venelin Dimitrov  "Our goal was to implement а serialisation and track & trace solution, which will fully comply and cover the requirements of the client and the European Union’s Falsified Medicines Directive. Our solution included 5 SoftGroup® SaTT Stand-alone machines with conveyor belt of only 80 cm, especially designed to fit the space constraints of the client. Moreover, we designed a new model manual serialization machine to cover the process and specific requirements of Thaikapharma to serialize specific size cartons."

  How did this contribute to your client’s success?

Venelin Dimitrov  "The implemented SoftGroup® SaTT solution helped Tchiakapharma in meeting the Directive 2011/62/EU requirements on time and be fully prepared even before the deadline on Feb. 2019. The client received a customized solution that fitted their specific needs and processes. Tchaikapharma is the fastest growing pharmaceutical manufacturer operating in Bulgaria. The company is focused on making available contemporary therapeutical solutions on the local, regional and European markets. Having a complete serialization solution implemented by SoftGroup helps Tchaikapharma achieve its goals and mission."

  What was the innovation within your project which made you win the 4th CEE Pharmaceutical Manufacturing Excellence Award?

Venelin Dimitrov   "We, at SoftGroup, develop our own solutions, which allow customization for each client.

In Tchaikapharma, we connected 3 production facilities in different locations - Sofia, Plovdiv and Varna. We managed to keep the secondary packaging with minimal changes and avoid major design changes on the lines, even though there was a severe lack of space. We successfully implemented our solution not only in automated lines, but also in a manual packaging area, and we guaranteed serialization solution with rejection rate below 0.01%.

The innovations in this project included:

- Designing serialization machines with conveyor belt of only 80 cm

- Designing special manual serialization machine

- Implementing rework functionalities for checking and decommissioning of serial numbers for lab testing and internal procedure purposes

- Providing connectivity with third parties (data exchange with CMO) – export batch data and serial numbers to CMO and import results from CMO

- Providing connection with the European Hub (EMVS)"

  How do you think the recognition is helping you to raise your brand awareness further?

Venelin Dimitrov  "The award gave us the opportunity to prove to all that our solutions meet every client's needs and we are ready to offer the best, based on their requirements. SoftGroup offers solutions and services that are compliant with the pharmaceutical industry standards. Every successfully completed project gives our present and future clients the confidence that they can rely on us."

  In your opinion, how is the award supporting the developments of manufacturing excellence solutions in the CEE region?

Venelin Dimitrov   "Having a Bulgarian IT company win this award is a great honour and acknowledgement of our efforts. This motivates us to exceed ourselves. Hopefully it will motivate other companies from the CEE region to develop their own solutions."

  From your perspective, which are the biggest challenges the pharmaceutical industry is facing nowadays in the CEE region?

Venelin Dimitrov   "With the upcoming deadline of Directive 2011/62/EU, Serialization and Track & Trace is the challenge most of the small and medium size pharmaceutical enterprises are facing at the moment. Most of them have not implemented any serialization solutions yet, and some of them have not even chosen an appropriate solution. These types of projects take up a lot of time and resources. If the pharmaceutical companies are not ready to meet the requirements by February 2019, they risk not being able to sell their medicinal products on the European market."

  How are you supporting your clients to overcome them?

Venelin Dimitrov   "SoftGroup is a complete Serialization and Track & Trace solution provider with focus on small and medium pharmaceutical enterprises. Our solutions and services include:

∙ Level 1 – Hardware: Serialization machine, Tamper Evident machine, Aggregation machine

∙ Level 2 – Line Controlling Software: controls the entire packaging line

∙ Level 3 – Site Controlling Software: controls all packaging lines and their modules

∙ Level 4 – Communication with 3rd parties: management of all serialization and regulatory data with partners, customers, subcontractors and regulatory authorities

∙ Level 5 – Regulatory Hub Connection: secure data transfer between Level 3 and EU HUB

Additionally, we are currently finalizing a special solution for the small pharmaceutical enterprises with only 1 production line. If you are interested in this solution, come by our stand at PHARM Connect or contact us and we will present it to you."

  Are you planning to apply for the award again in the future?

Venelin Dimitrov   "With every next project that we have, we develop and improve our solution. We become more flexible and innovative. Therefore, when we make out the next big project, it will be a pleasure for us to present it to the pharmaceutical industry."

  Are you planning to attend PHARM Connect again next year?

Venelin Dimitrov   "We will definitely participate in PHARM Connect next year. This is a big opportunity to meet other companies in the industry and to exchange expertise."

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We are passionate about bringing together annually in Budapest the best representatives and innovators of the pharmaceutical industry to create a valuable and engaged professional network in Central and Eastern Europe. If you think your solution is cutting-edge and should be recognized by the industry, apply for the next CEE Pharmaceutical Manufacturing Excellence Award and put your business in the spotlight by presenting your solution at the upcoming PHARM Connect Congress!

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