Develco Pharma is a privately owned company operating in the field of development and manufacturing of pharma-ceuticals, with their own packaging and production lines processing over 750 articles. Although their headquarters are in Switzerland, their manufacturing site is located in Schopfheim, Germany. They produce medicines and active substances for the treatment of severe pain (opiates) that are subjected to strict regulations and procedures in nation-al and international markets. As CMO and virtual CMO deal-ing with a business so complex in nature, Develco Pharma have been granted a high level of recognition among the experts and distributors in the pharmaceutical industry.

With the Delegated Regulation (EU) 2016/161 directive due in February of 2019, it was vital for the company to undertake a project that would make them compliant in every aspect of their business. Because of their status as virtual CMO, it increased the amount of required planning to coordinate all the participants in the production process. Not only did Develco Pharma need to make sure that they fulfilled CMO and opiate regulation requirements, but also that they had enough serial numbers at all times in order to ensure a smooth production process.

COMPLIANT PROCESS WITH MANY BUSINESS PARTNERS ON TIME AVAILABLE

AT A GLANCE

Challenges Ensure the new and compliant process is up

and running on time Extensive coordination requirements due to the

amount of involved business partners Large amount of articles had to be imported

Solution highlights Eliminate risk of errors by using an automated tool

for article import Many business partners connected to one account

in a short amount time Use of a solution hosted by Arvato Systems

Advantages Use of a specialized tool Experts in serialization with extensive experience Continuous consulting Transition without variation in productivity

Develco Pharma GmbHFounded in 2006 with headquarters in Pratteln, Switzerland, Develco Pharma has a production site in Schopfheim, Germany. The company develops and produces pharmaceutical products that aim to treat severe pain. They are a CMO and virtual CMO with access to European, American and African markets, and plan to expand their presence to Asia and Australia.

DEVELCOPHARMA

Dr. Benedikt Freund Project Manager | Consultant Systec & Services GmbH benedikt.freund@traxeed.com

www.traxeed.com

© S

yste

c &

Ser

vice

s G

mb

H ·

All

right

s re

serv

ed ·

12.

2019

EN

· W

e ar

e no

t lia

ble

for

any

erro

rs.

Tech

nica

l mod

ifica

tions

are

sub

ject

with

out

furt

her

notic

e. A

ll tr

adem

arks

, tr

ade

nam

es a

nd c

omp

any

nam

es r

efer

ence

d h

erei

n b

elon

g to

the

ir re

spec

tive

com

pan

ies.

SolutionThanks to the overwhelming success of a previous project where Systec & Services installed a third party MES system, Develco Pharma chose to further trust Traxeed’s experts. The Arvato CSDB system, which is hosted on the Arvato Systems servers in Germany, was chosen as a solution. This ensures that the company and all its business partners have data that is compliant with the EU directive and available in the EU Hub.

Since there were over 20 business partners to connect, Traxeed’s experts had to maintain close contact with each of the companies’ involved departments (e.g. supply chain, production) and respect a strict timeline.

ImplementationOne of the main challenges during this project was to establish and maintain adequate communication between the involved parties (MAHs, CMOs, virtual CMO). Over 20 business partners had to be connected to the system, and this was only possible through regular and frequent exchanges. The project was divided into 2 phases. Firstly, Develco was connected to the Arvato CSDB system. Traxeed provided constant support and consulting, and the experts regularly visited Develco on site for personal assistance.

Thanks to a specially developed Traxeed Tool, all 750 articles were automatically imported into the database within a remark-ably short amount of time, using a simple excel sheet. Second-ly, the Traxeed team worked with Develco’s business partners and the different departments involved with serialization (pro-duction, supply chain, IT, QA…) in order to connect them with that account. Through excellent project management skills and effective collaboration, the project was a success.

ResultDespite the challenges posed by time constraints and com-munication difficulties, all timelines were met within the bud-get and in the desired quality. Through Traxeed’s resourceful-ness and effectiveness, complications that arose during the process due to a business partner’s technical difficulties were quickly mastered. Thanks to the teams’ hard work, Develco Pharma and all business partners were compliant and ready for production in February of 2019.

“It is reassuring to work with a team that knows what it is doing. We knew that we could count on Traxeed to deliver, as they have always been a reliable partner.

Through their professionalism and expertise the project unfolded smoothly, and we look forward to working with

such a dedicated team for any future projects.” Dr. Thomas Koy Develco Pharma

“It was a pleasure working with such a committed team. The communication was excellent, and through our joint efforts we were able to achieve our common vision. We heartily thank Dr. Thomas Koy and his team for their collaboration, and look forward to future successful projects!” added Dr. Benedikt Freund, Project Manager, Traxeed.

ABOUT TRAXEED

Traxeed is your partner for complete pharma seria-lization solutions. Their highly qualified experts with extensive experience in the industry provide their sup-port at all levels, from serialization and aggregation machines to software and implementation. For this, Traxeed bundles Seidenader‘s know-how in Track & Trace and aggregation machines and the neces-sary software for levels 1 to 3 as well as the expert knowledge of Systec & Services in the implementation of levels 1 to 5.

Traxeed is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber.