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Who we are

Xendo is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices and healthcare. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Over 150 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support and training; providing a full-colour spectrum.

Our clients

The spectrum of our fields of expertise is as broad as the range of clients we work for, enabling us to cater to the varied needs and wishes of the Life Science industry. We bring our palette of services to companies, ranging from start-ups to multi-national organizations, to provide them with robust solutions. Whether they are a (bio)pharmaceutical or medical device company, a hospital or a pharmacy, a manufacturer or a laboratory, we match their colour.

16-01-2017
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#Xendo BV acquires Sofus Regulatory Affairs AB

Xendo, the Life Sciences consultancy company, is pleased to announce that it has acquired the Swedish consultancy company Sofus Regulatory Affairs AB. Sofus is based in Stockholm and provides regulatory affairs services for all phases of the pharma and biotech development, from early development projects to post-approval services including pricing and reimbursement issues, and has a strong position in the Nordic countries. This acquisition will strengthen the two companies to continue providing the highest levels of consultancy services within the Life Sciences industry. Through this collaboration, both companies will be able to offer new services to their customers in an expanded region.

Xendo was founded in 1990 and is now a leading, independent consultancy and project management organization in the (bio)pharmaceutical, medical devices, and healthcare fields. Xendo currently employs over 150 experienced and highly educated professionals. The areas of expertise include a.o. Regulatory Affairs, Pharmacovigilance, Compliance & Validation, and Engineering & Technical Support.

Sofus was founded in 2002 and is the leading Nordic regulatory consultancy, supplying comprehensive regulatory, quality and safety solutions, to both multinational corporations and small businesses in the Nordics and in Europe. Sofus currently employs around 55 people.

André van de Sande, CEO, Xendo comments: “I am delighted to be leading Xendo in this next phase of growth. The addition of Sofus to Xendo will strengthen our position as a trusted advisor in Life Sciences. We operate in an exciting market and this acquisition offers a real opportunity to further develop Xendo’s services and extend our geographic reach. I am looking forward to working with Linda Thunell and her team.”

Linda Thunell, CEO, Sofus added: “This was a natural step for us in the further development of our business. As part of the Xendo group we will be able to strengthen our presence on the international market and at the same time offer a broader range of services to our clients. Our companies are a good match and together we will be able to offer more of the very best services to our clients.”

For further information, contact:


André van de Sande – CEO Xendo
T: + 31 (0) 71 524 4000
E:
W: www.xendo.com
W: www.sofus.se

06-01-2017
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#IVD & MD CLASSIFICATION

How to classify your Medical Device or In Vitro Diagnostic under the new regulation

Medical Devices have been classified under the Medical Device Directive as 1, 1m, 1s, 2a, 2b and 3. With the increase of the class, the inherent risk increases too. As a result, the regulatory requirements will increase too, not only in number but also in nature. Under the new Medical Device Regulation this approach remains.

For In Vitro Diagnostics the new IVD Regulation will also apply a risk-based approach, which could be regarded as a paradigm shift with respect to the IVD Directive. The classes for IVDs range from A to D, with D the highest risk class. Also for IVDs the new approach will result in stricter regulatory requirements for higher class IVDs.

To assist you in your efforts to classify your IVD or Medical Device we have put the criteria according to these novel regulations in a flowchart.

Feel free to contact us in case of additional questions!

View chart here.

Contact: Marc Klinkhamer - Principal Consultant at Xendo

Email:

13-12-2016
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#Xendo announces management buy-out supported by Sovereign Capital

The investment will strengthen the company’s position as a leading consultant and it will have a positive effect on the continuity of business. Current customers will continue to seamlessly enjoy existing services, and Xendo will be able to seek to expand its services and geographical reach, both through organic growth and complementary acquisitions. With a strong track-record as a ‘Buy & Build’ specialist, Sovereign Capital will provide the financial support to grow, develop and expand Xendo.

Under the new ownership the business will continue to operate under its own name. We are also delighted to welcome CFO, Arjen Huijs (previously Jacobs Douwe Egberts) to the current management team.

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13-12-2016
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#Xendo makes the Dutch Financial Times (Financieel Dagblad)

BIO International Convention 2016

Xendo CEO, André van de Sande, brought one of our customized VANMOOF bikes to this years' BIO International Convention in San Francisco.

BIO International Convention 2016

Approximately 400 participants showed that the raffle was a huge succes and attracted a large crowd. We wish to congratulate this years' winner, Ruud Smits of NautaDutilh. We are very much looking forward to another succesful BIO again next year!

Biotechbedrijven dromen zich rijk na megadeal Acerta

13-12-2016
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#Xendo makes the Dutch Financial Times (Financieel Dagblad) again!

Xendo's recent management buy-out by Sovereign Capital has grabbed the attention of the Dutch Financial Times, which placed an article about it today.

In response to questions by FD-journalist Thieu Vaassen,  André van de Sande (CEO) gives insight in Xendo's successful turnaround over the past 5 years.

To read the article (in Dutch) follow this link.

13-12-2016
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#Xendo – Vigilex accepted as candidate for Deshima Business Award 2016

The Deshima Business Awards are granted to Dutch companies in recognition of successful business achievements in the Japanese market and are awarded by the Netherlands Chamber of Commerce in Japan.

Xendo-Vigilex has shown rapid development, having grown from 60 to over 150 employees over the past years. Next to realizing excellent growth of our European offices, this candidacy shows Xendo-Vigilex is also successful with our Japanese operation. Xendo-Vigilex offers a full scope of pharmacovigilance activities and is successfully supporting many Japanese (bio)pharmaceutical companies, who conduct clinical studies or market their product(s), or intend to, in the EU or US. Besides visiting our customers face-to-face several times a year and having local representation, Xendo-Vigilex also organizes a yearly seminar in Japan, which focuses on understanding EU PV related legislation and guidance on how to implement this in daily business.

Even though the market is competitive, we continuously see growth opportunities for our business and the nomination for the Deshima Business Award confirms this.

13-12-2016
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#Xendo awarded for the second year in a row as FD Gazelle

Xendo was named an FD Gazelle 2016, meaning we belong to the fastest growing companies in the Netherlands again. The Gazelle Awards, an initiative of the ‘Financieele Dagblad’ (Dutch Financial Times), are awarded annually to the fastest growing enterprises, where the main criterion is a turnover growth of at least 20% per year during a three-year period.

André van de Sande (CEO, Xendo) says:

We have realised excellent growth over the past years and we have grown from 60 to over 150 employees. This is the second year we have been awarded a Gazelle, meaning we are showing robust growth of our company. Although we are operating in a competitive market, our clients increasingly know how to find us and we would like to thank them for the trust they place in Xendo.

08-12-2016
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#IDMP compliance: 7 channels to get informed

Starting from mid-2018, all pharmaceutical companies having medicinal products registered on the EU market will have to have submitted IDMP-compliant data for these products. IDMP stands for identification of medicinal products and refers to five ISO standards defining terms and structures to uniquely identify medicines. While big pharmaceutical companies usually have projects started to ensure IDMP-compliant submission and maintenance of the data, SME companies are mostly still in a phase of orientation.

SME companies are currently analysing the requirements to create their own company approach towards compliance and to estimate the cost of it. Most SME companies plan to start projects in 2017 when detailed guidelines for IDMP requirements are to be published by the EMA.

SME companies usually face the following challenges on their way towards IDMP compliance:

Internal Resources

  • Usually no dedicated function for master data management/ regulatory data management
  • Limited resources available to train employees on IDMP requirements and to keep up to date with changing information

Cost

  • Limited financial resources for additional software
  • Limited resources (FTE/external costs) for data collection/ submission/ maintenance

Lack of Benefit

  • No internal business case for IDMP compliance: IDMP compliance is cost only

Limited Official Information

  • Final timelines not published by EMA yet
  • Final requirements not published by EMA yet
  • EMA database not published yet

However, IDMP compliance is not a mystical quest that cannot be solved by common sense. This post will describe 7 different channels of how to stay informed about IDMP requirements and implementation plans of the EMA and will compare their efficiency for SME.

Information Channels for SME Companies

One major challenge for SME companies is to stay informed about authority plans and requirements for IDMP compliance. While requirements are being defined and implementation plans are being changed by the EMA, direct information from EMA has been very scarce over the last years.

The following sources to stay updated about IDMP should be considered:

1. EMA website

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp

EMA publishes official information regarding IDMP implementation on its website. The website also includes a webinar given by the EMA in August 2016 as well as meeting notes from the IDMP task force.

2. ISO standards and implementation guides

The ISO standards and ISO implementation guides can be bought online. They are currently under revision and new versions are expected in 2017 (for standard 11615 and 11616 in the second quarter, for standard 11238 in the fourth quarter, for implementation guide for ISO 11238 in the first quarter, for implementation guide for ISO 11615 in the second quarter of 2017).

The ISO standards ISO implementation guides will serve as a basis for the EU implementation guides. The EU implementation guides will define the actual requirements for the EEA and are currently created by the IDMP task force.

As long as EU implementation guides are not available, ISO standards and implementation guides give the most detailed information on which requirements for IDMP compliance can be expected. Special attention should be paid to the standards of the medicinal product and substances as well as the technical implementation guides.

3. Direct via IDMP task force

The EU IDMP task force consists of representatives of EU institutions like the EMA and NCAs, representatives of the pharmaceuticals industries and other interest groups like vendors. The task force is developing and implementing IDMP requirements in the EU. For big pharmaceutical companies and vendors in the area of RA data organisation, participating in the IDMP task force also serves as a direct channel to the implementation of IDMP. However, even within the task force, a lag of information delivery from EMA to industry/vendor representatives prevailed.

Participating in the IDMP task force does not only require sufficient time but also specific knowledge in the field. Therefore, it seems natural that this is not the information channel of choice for SME companies. However, information from recent task force activities can be found on the EMA websites in the task force meeting minutes and are also exchanged via the IRISS forum as described in point 2.1.6.

4. Conferences, external training

Since 2014, the number of conferences and professional training focusing on IDMP has steadily risen. Speakers from industry, vendors, and authorities can give valuable insights to their IDMP implementation projects. However, again mostly big pharma companies are attending, as conferences and training are costly and SMEs lack functions dedicated to the subject. Bigger companies already involved in internal IDMP projects are often updated by vendors and consultancies part of the project team.

SME companies not starting IDMP projects yet might consider using an in-house training held by experienced consultancies to inform all involved functions about IDMP instead. 

5. Informal networking

As official information from the EMA has been scarce, direct information from task force members has proven a helpful source of information. Informal exchange based on personal contacts also is highly helpful when implementing IDMP within the own organisation. Related functions in other companies usually face similar problems and solutions and experiences can be exchanged. Again, big pharma companies with functions dedicated to the subject have been in advantage here while RA departments often feel responsible for IDMP in SME companies. Nevertheless, exchanging experiences regarding IDMP implementation with related functions in other companies can be a highly useful, cost- and time-efficient source of information for SME companies as well.

6. IRISS forum

https://www.iriss-forum.org/

The IRISS forum refers to itself as “A Non-Profit Dedicated to Implementation of Regulatory Submission Standards Around the World”. Related subjects are discussed within topic groups and webinars, members come mostly from industry and vendor organisations. The IDMP topic group meets in a monthly t-con. The agenda usually focuses on recent activities of the EU IDMP task force and of the ISO technical committee currently updating the ISO standards. Speakers usually are members of both organisations. IRISS members can add questions, issues regarding xEVMPD activities are discussed as well. Records, as well as notes of the meetings, are published afterward. The forum also conducts surveys and collects feedback for the EU IDMP task force from its members.

As membership is comparatively inexpensive, SME companies should consider it as a cost- and time-efficient source of up to date information.

7. EMA efforts to cascade information

In its August webinar, EMA described its approach to set up a change network to cascade information regarding IDMP more efficiently. EMA will appoint industry change liaisons. Industry change liaisons will come from the IDMP task force. They are meant to cascade information and best practices directly and interactively to industry as well as to give feedback to EMA change network if additional communication is needed. They are meant to work together with key contact points at industry organisations to identify suitable communication channels like conferences or forums where they can present and communicate about IDMP. The industry is asked to get in touch with industry change liaisons if opportunities are identified that they can communicate with a wider range of industry stakeholders.

EMA promised to publish contact information of industry change liaisons soon. It needs to be evaluated how effectively they will improve communication. SME companies might want to contact their industry organizations regarding any related activities planned.

According to EMA, the SME office is also responsible for cascading information to SME and registered SME companies can submit questions there as well.

Considerations

In August 2016, the IRISS forum conducted a survey of its members about their IDMP compliance activities. The results are publicly available: https://www.iriss-forum.org/news/iriss-publishes-the-results-readiness-surveys-for-idmp

One of the questions asked was how companies stay informed about IDMP compliance.  Most of the 29 industry members answering the survey reported that they received information about IDMP implementation either directly from the task force, via the IRISS forum or from vendors and consultancies. When asked about their preferred source of information, however, almost all companies reported that they wish to receive information directly from the authorities.

While it is unclear whether more information directly from the EMA will be available in the future, companies currently are still asked to use various other information channels.

For SME companies the following approach can be helpful.

  1. Start with an in-house workshop to bring all involved functions to the recent level of IDMP information. The workshop should also answer all open questions regarding the contents of the ISO standards and ISO implementation guides. Xendo offers workshops as part of its IDMP consultation services. Please contact us for more information.
  2. Stay informed about new information using the following channels:
    The EMA website should be checked regularly for any updates
    Appoint a function to follow the discussions on the IRISS forum

Network with peers to get informed about experiences from organisations similar to your own.

Feel free to get in touch for some additional information!
Blog by: Almut Holz - Managing Consultant at Xendo 
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