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Pharma 4.0 Download

Pharma 4.0 [Download expert presentation]
January 9, 2019

Valentino Ducati, Management Consultant Information Management, and Volker Roeder, Management Consultant Compliance, presented in June 2018 at an expert conference Pharma IT Compliance in Bonn on the topic “Pharma 4.0 | Digitalization in ... More
ARCONDIS donation campaign 2018

ARCONDIS donation campaign 2018
January 8, 2019

Last December we organized our annual donation campaign in which we donate ten Swiss francs on every participants behalf, and you choose the aid organization. More than two hundred customers and partners participated in our campaign. ARCONDIS ... More
Donation campaign Christmas and New Year 2019

Merry Christmas and a successful New Year 2019!
December 6, 2018

Together with a heartfelt Thank You for the trusting cooperation this year we wish you a wonderful Christmas time. Once again this year we would like to support with our fundraiser those who are in urgent need. By selecting one out of three aid ... More
Graduate Consulting Club Event with ARCONDIS

Meet ARCONDIS at the Graduate Consulting Club [Career Event]
November 14, 2018

Do you strive for a career in consulting? Meet us on December 4, 2018 at the networking event of the Graduate Consulting Club of the University of Basel. Annett Stehr, HR Manager, and Lars Schmiedeberg, Manager Compliance, introduce ARCONDIS as ... More
ARCONDIS Newsletter "UPDATE" third Issue 2018

ARCONDIS Newsletter “UPDATE” – third issue 2018 published
October 25, 2018

The new UPDATE is out! In the latest issue of our newsletter, we inform our customers within the life sciences about current industry trends and topics such as: Is Agility the recipe for success? Patient Journey – Optimizing digital ... More
"Life Sciences" Special Edition of the Basler Zeitung

“Life Sciences” Special Edition of the Basler Zeitung
September 20, 2018

On September 7, 2018 the annual special edition “Life Sciences” of the Swiss newspaper Basler Zeitung (BaZ) was published. Amongst other interesting topics on innovation in the life sciences, ARCONDIS contributed not one but two ... More
DBRT Event: Digital Transformation Life Sciences

Digital Transformation in the Life Sciences Industry [DBRT Event]
September 14, 2018

What is the Digital Transformation and how is it different from what we have been doing with IT in the past thirty years? What are its implications and the key factors for organizations to be successful? How to develop a Digital Strategy? What ... More
Webinar Serialization downloads

Downloads webinar serialization of medicinal products
July 4, 2018

Serialization – are you ready to fulfill the new requirements? With the deadline rapidly approaching, how many of the following challenges have you successfully addressed? Implementation of a compliant IT landscape and standardized ... More
ARCONDIS Newsletter "UPDATE" second Issue 2018

ARCONDIS Newsletter “UPDATE” – second issue 2018 published
June 21, 2018

The new UPDATE is out! In the latest issue of our newsletter, we inform our customers within the life sciences about current industry trends and topics such as: The life sciences need a new digital boost – get involved now! MDSAP – ... More
GDPR in Life Sciences and Healthcare

GDPR in Life Sciences & Healthcare
May 16, 2018

The heat is on: the two-year transition period for the new European General Data Protection Regulation GDPR / EU-DSGVO will be over on May, 25th. Where does your company stand? Compliance with GDPR requirements doesn’t have to be complex or ... More
Digital Transformation & Digitalization in Life Sciences & Healthcare

Digital Transformation and Digitalization
May 3, 2018

Take advantage of opportunities through new technology. ARCONDIS manages Digital Transformation for the life sciences and healthcare industries from strategy to implementation. More
IDMP Update Jahr 2017 / 2018

IDMP Update 2017 / 2018
April 5, 2018

Though no binding specifications have been issued by the European Medicines Agency (EMA) for when the IDMP (Identification of Medicinal Products) regulation has to be implemented, quite a bit has happened in the area over the past few months. ... More
Fiscal Year 2017 - Erwin Kueng, CEO

Fiscal year 2017
March 22, 2018

Basel/Frankfurt/Munich, March 22, 2018: Consulting firm ARCONDIS, specialized in the life sciences industry, has wrapped up its 16th fiscal year with a solid group revenue of 22.1 million Swiss francs. For German associate ARCONDIS GmbH with ... More
Medical Device Regulation (MDR) - Webinar Downloads & Video

Webinar Downloads: Medical Device Regulation (MDR)
March 13, 2018

The new European Medical Device Regulation (MDR) was published in May 2017. There are significant changes to the Medical Device Directive impacting every major department in every company ranging from R&D to Production, Regulatory, Quality ... More
Digitalization of Switzerland

WEF Breakfast with digitalswitzerland
March 6, 2018

 A panel discussion and breakfast event, the “WEF Breakfast” was held at the World Economic Forum (WEF) in Davos at the end of January 2018. Under the banner “Switzerland, the world’s most innovative country at the intersection ... More
ARCONDIS Newsletter UPDATE 1 2018

ARCONDIS Newsletter “UPDATE” – first issue 2018 published
March 1, 2018

Life sciences trends 2018, a lean, future-proof IT quality management and digitalization in the GxP environment In the new issue of UPDATE, the regularly published ARCONDIS newsletter, we inform our customers within the life sciences industry ... More
Webinar Serialization

Webinar Serialization of medicinal products [Free – German only]
February 20, 2018

Falsified medicines present a major threat to public health, as well as damaging the reputation of pharmaceutical brands. The Falsified Medicines Directive (FMD) determines that the serialization of medicinal products will be a legal requirement ... More
Top Employer 2018

Top Employer 2018
February 14, 2018

The magazine FOCUS-BUSINESS has rated ARCONDIS one of the top employers in the areas of “consultation” and “SMEs” in German-speaking countries, on the basis of an independent data collection. Overall, ARCONDIS was ranked in place 211 out of the ... More
MDSAP – Medical Device Single Audit Program

MDSAP – Medical Device Single Audit Program
January 22, 2018

The stated aim of the Medical Device Single Audit Program (MDSAP), which officially took effect in June 2017, is to reduce audit effort for quality management systems (QMS) for authorities as well as for medical device companies. The ... More
ARCONDIS donation campaign 2017

ARCONDIS donation campaign
January 5, 2018

Last December we organized our annual donation campaign. The idea is simple: You choose the aid organization and ARCONDIS donates ten Swiss francs on your behalf. Around two hundred customers and partners participated in our campaign and ... More
Donation campaign Christmas and New Year 2018

Merry Christmas and a successful New Year 2018!
December 12, 2017

Many thanks for placing your trust in us and for the pleasure of working with you in 2017. As in previous years, we would like to support those who urgently need our help with our donation campaign. Please participate by deciding how we should ... More
EU-FDA Mutual Recognition Agreement (MRA)

EU-FDA Mutual Recognition Agreement (MRA) has come into force
December 5, 2017

On November 1, 2017 the Mutual Recognition Agreement (MRA) between the EU and US came into force. It defines the future cooperation between the FDA and EU regulatory authorities and stipulates mutual recognition of audits of pharmaceutical ... More
Success Story Vifor Pharma

Efficient Quality Reporting for Vifor Pharma
October 31, 2017

Price pressure and tough competition are driving pharmaceutical companies to higher quality and continuous improvement. The quality management department of Vifor Pharma is making its own contribution and prescribed a slimming diet to its own ... More
ARCONDIS Newsletter UPDATE 3 2017

ARCONDIS Newsletter “UPDATE” – third issue 2017 published
October 24, 2017

Digital Foundation, Lean Compliance and Agile Validation In the new issue of UPDATE, the regularly published ARCONDIS newsletter, we inform our customers within the life sciences industry about Digital Foundation Lean Good Distribution Practice ... More
MDR Webinar

Medical Device Regulation [MDR Webinar]
October 18, 2017

A free webinar on How to Achieve Benefits from MDR Compliance The new European Medical Device Regulation (MDR) was published in May 2017. There are significant changes to the Medical Device Directive impacting every major department in every ... More
EU FMD (Falsified Medicines Directive)

Are you prepared for EU FMD?
September 19, 2017

As the pharma industry prepares for the EU Falsified Medicines Directive deadline, which is a little over 500 days away, TraceLink Europe, our partner in serialization, is organizing an educational workshop. Hear from Volker Roeder, ARCONDIS’ ... More
10 years of ARCONDIS Germany

Intelligent solutions for life sciences
September 1, 2017

The German subsidiary of the ARCONDIS Group is celebrating its ten-year anniversary. Founded in 2007, ARCONDIS GmbH, based in Frankfurt, is today one of the leading consultancy firms in the life sciences industry in Germany, and offers an ... More
ARCONDIS Newsletter UPDATE 2 2017

ARCONDIS Newsletter “UPDATE” – second issue 2017 published
July 20, 2017

GxP in the Cloud, Agile Project Management and Digital Health Care - in the new issue of UPDATE, the regularly published ARCONDIS newsletter, we inform our customers within the life sciences industry about ... More
IDMP Readiness survey 2017

IDMP Readiness Survey
June 21, 2017

Are you ready for IDMP compliance? ARCONDIS is conducting  an online survey for pharmaceutical companies to assess the current state of IDMP readiness within the industry. Background Since the EU has published the implementing regulation (EU) ... More
MDR Compliance - Medical Device Regulation

MDR Compliance
May 24, 2017

After years of tough negotiations, the new European Medical Device Regulation (MDR) is officially taking effect on May 25th, 2017. Medical device manufacturers can expect considerable additional burdens for the MDR Compliance.   MDR ... More
Data Integrity Webinar - Downloads

Data Integrity [Webinar Downloads]
May 17, 2017

In April and May 2017 ARCONDIS did a webinar series on Data Integrity in the life sciences industries (see: Why should care about Data integrity). As of now you can download the presentation and the video recording of the Data Integrity Webinar ... More
ARCONDIS Newsletter "UPDATE" first issue

ARCONDIS Newsletter “UPDATE” – first issue 2017 published
April 27, 2017

With UPDATE, the regularly published ARCONDIS newsletter, we inform our customers in the life science industry about interesting facts, news and upcoming trends – combined with our practical experience from years of consulting. Take a look at ... More
Employer Ranking

Employer Ranking
April 11, 2017

In 2016 ARCONDIS AG proved to be one of the best employers in Switzerland. We entered for the second time in succession the top 10 of kununu’s employer ranking for consulting. Particularly equality, solidarity among colleagues, and the work ... More
Biovalley Companies Day

Biovalley Companies Day – Partnering Event on March 28, 2017
March 11, 2017

On March 28, 2017 the 6th „Biovalley Companies Day“ is hold in Freiburg, Germany, and ARCONDIS will also be taking part. At „Companies Day“ companies in the biotechnology industrie and services providers in related industries present their ... More
Data Integrity Webinar

Data Integrity [Webinar]
February 7, 2017

Data is the foundation on which you run your business. The aim of data integrity is not only to make the right decisions and to stay compliant, but also to extract the most value from your corporate data. In life sciences, incomplete or ... More
General Data Protection Regulation (EU GDPR)

General Data Protection Regulation (EU GDPR)
January 31, 2017

In May 2018, the EU’s new General Data Protection Regulation (GDPR) will enter into force and replace former national legislation. This will affect not only organizations in the EU’S member states, but all organizations worldwide that collect or ... More
Charity Concept

Fundraising – ARCONDIS supports children and adults in need
January 13, 2017

In recent years, ARCONDIS initiated a fundraising during advent time, and we continued this tradition in December 2016. Thereby, ARCONDIS donates ten Swiss francs in your name to the organization of your choice. More than 250 customers and ... More
Donation campaign Christmas New Year

Merry Christmas and a successful New Year 2017!
December 14, 2016

Many thanks for placing your trust in us and for the pleasure of working with you in 2016. As in previous years we would like to support those who urgently need our help with our donation campaign. Please participate by deciding how we should ... More
Falsified Medicines

Falsified Medicines
November 23, 2016

The EU GMP Annex 16 has been revised in order to reduce the risk of undiscovered sub-standard medicines in the supply chain. Using the example of one of our customers we present the guideline’s requirements and show how to fulfill these in ... More
ARCONDIS Consulting Team

Even more consulting power for our life sciences customers
October 21, 2016

Digital transformation, stricter compliance requirements and restructuring: the demand for consulting in the life sciences industry is alive and well. ARCONDIS is responding to the growing project requirements and is equipping its consulting ... More
Project Health Check [Project Audit]

Project Health Check [Project Audit]
August 17, 2016

What is the difference between the Berlin-Brandenburg Airport and the railway tunnel through the Gotthard? Or in other words, what have the people in charge of the construction project done better to not only complete their project successfully, ... More
MHRA GxP Data Integrity Guidance

MHRA GxP Data Integrity Guidance – Revised Version Published
August 4, 2016

18 months after the publication of „GxP Data Integrity Definitions and Guidance for Industry” the British regulatory agency MRHA has now submitted a new draft of said document. Thereby, MHRA underpinned the increasing importance of data ... More
GXP cloud computing whitepaper

GxP in the Cloud [Whitepaper]
July 20, 2016

In about half of German companies they are already in action – cloud solutions. By 2017, the share of cloud usage will increase to 77 percent. However, this development raises major concerns, especially in the life sciences industries, because ... More
ISO 13485:2016 Medical Devices Management

ISO 13485:2016 – New requirements for the medical devices sector
July 20, 2016

The production of medical devices is highly regulated, which is reflected particularly in EU regulations and standards. If one of these standards is updated in response to rapid progress, it is crucial to react fast and to implement the required ... More
Peter Bunse, CEO ArcondisGmbH, Germany

Interview with Peter Bunse
July 4, 2016

Peter Bunse, CEO of ARCONDIS GmbH     The new CEO of ARCONDIS GmbH, an avid fan of the life sciences, and a passionate pioneer – this is Peter Bunse. During our initial interview, he told us about the future of the life sciences, about ... More
Information Landscape

A map for your processes
June 13, 2016

The pharma technical development wants more: gain more value from its information. Better support by systems and platforms. And a wise prioritization of investments. In order to achieve this goal, the department got ARCONDIS on board: The ... More
Data Integrity & Compliance for cGMP

FDA Guidance – New Document Published for Data Integrity & cGMP
May 17, 2016

The FDA’s new Draft Guidance is its response to the increase of data integrity violations registered by the regulatory authority over the last years within the framework of cGMP inspections. On many occasions, it sanctioned manufacturers ... More
Agile Validation of Mobile Applications [Download Presentation]

Agile Validation of Mobile Applications [Download Presentation]
April 27, 2016

How can agile software development stay compliant to the life science industry’s regulatory requirements? The key is agile validation. Especially for mobile applications, agile project management methods such as SCRUM are beneficial. Concerning ... More
Christian Baumgartner and Erwin Küng

Fiscal Year 2015: Expanded Specialization with Stable Revenue
April 7, 2016

Reinach, Basel / Eschborn, Frankfurt / Munich, April 6, 2016: The consulting company ARCONDIS, exclusively specialized in the life science industry, concludes its 14th financial year with a stable group revenue of 22,5 million Swiss francs. The ... More
Annex 15 Process Validation

Annex 15 Process Validation [Download Presentation]
April 5, 2016

How can we implement continuous validation into our daily business in an efficient way? And what are the implications of continued process verification with regard to change and risk management? The new Annex 15 guideline is a paradigm shift, ... More
ARCONDIS workshop agile validation

Agile Validation of Mobile Applications [Workshop]
March 10, 2016

In the era of industry 4.0, mobile applications determine our daily business more and more. Therefore, especially the life science industries face new challenges. Classical approaches such as the V-Model often do not satisfy these complex ... More
New Management of ARCONDIS in Germany - Press Release

New Management of ARCONDIS in Germany – Press Release
March 2, 2016

Reinach, March 1, 2016: Peter Bunse takes up the position of Managing Director at ARCONDIS in Germany. He can look back on 20 years of experience in the development and management of service units, which are specialized in the consultation of ... More
IT Services in the Cloud

GxP in the Cloud. Quo vadis?
February 1, 2016

By 2017, 77% of German companies will use a hybrid cloud, according to the result of a study by the IDC at the end of 2015. It is hardly surprising since the technology promises flexibility and cost efficiency. For the question is also thrust on ... More
ARCONDIS Logo

ARCONDIS builds bridges
February 1, 2016

In the past 15 years, ARCONDIS has achieved a lot, and has evolved and developed professionally. In the projects that we realize for you, we make the connection: between specialized departments to IT, between quality and compliance ... More
Process Validation – Conference in Berlin

Process Validation – Conference in Berlin
February 1, 2016

With their “Guidance for Industry Process Validation: General Principles and Practices”, FDA proposes a new direction for process validation as a three-stage life cycle process: ChemAcademy’s international conference (February 29 to ... More
ARCONDIS new year

A successful future
February 1, 2016

Last December we called for supporting Arcondis in donating to humanitarian and social projects on your behalf. More than 250 customers and partner participated in our Christmas campaign and increased the Arcondis donation sum by a click for the ... More