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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 230 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.

24-11-2017
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#Slide Deck: Changes in the Medical Device Legislation; the day after.

Feel free to download the slide deck of one of our recent talks on the new Medical Device Regulation which was presented by Jan Bart Hak at the autumn meeting of the Pharmacovigilance  Platform Netherlands on November 21st, 2017.


The European Medical Device Regulation 2017/745 (MDR) is published on May 5, 2017, in order to replace the current Medical Device Directive 93/42; it will apply 3 years after this date. Requirements related to the technical file and procedures will be significantly reinforced, without the possibility of grandfathering.

These new requirements will affect the entire medical device (MD) industry with products in the EU. This implies that companies with products on the market within the European Union will need to come up with a transition plan to comply with these new rules and they have until May 25th, 2020 to do so.

A short calculation tells us that the countdown is at two and a half years at this point. As an example, in case the clinical evidence needs to be updated, one must start now. Clinical evidence can be collected in a clinical investigation or via post-marketing surveillance, which includes vigilance and post-marketing clinical follow-up studies. If a medical device company does not start now, it can be too late risking the CE mark and so market access.

Click here for the PDf of the full slide deck.

21-11-2017
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#MDR: Why you should start now or lose money!

Although the new Medical Device Regulation (MDR) is now officially effective (in co-existence with the Medical Device Directive, MDD) we’ve noticed that some companies are well on their way with the transition (mostly EU companies) but here seems to be only a small percentage of US companies that has actually started to transition from MDD to the MDR. Especially for Regulatory Affairs (RA) managers this might be frustrating because they are well aware that from short-term perspective sticking your head in the sand, in the long run, might cost you serious money. Here’s why.


MDD TO MDR


For those who haven’t yet had the time to investigate what (mandatory) changes the future holds in the Medical Device field, we can summarize it as follows: requirements regarding your product are increasing and becoming stricter. Examples are requirements regarding, risk classification, clinical evidence, Economic Operators, and Post-Marketing Surveillance. All currently certified Medical Devices (MDs) must be re-certified in accordance with these new requirements.
First of all, companies are well-advised to perform a GAP-analysis to see how they want to proceed with their product. Three likely outcomes could be:

  1. You find no go GAPs which means ‘no worries’.
  2. Major GAPs meaning there’s a lot of work and you should start rather sooner than later.
  3. So many GAPs that you might consider discontinuing your product and withdraw it.


This implies that companies with products on the market within the European Union who find themselves in the second category will need to come up with a transition plan to be compliant with these new rules and they have until May 25th, 2020 to do so. A short calculation tells us that the countdown is at two and a half years at this point.


To assist RA managers eager to start a possible transition we’ve lined up some situations that might motivate all their colleagues to set things in motion. We suggest exploring the three most likely options that could be considered.


1. WHAT IF I DON’T?


Definitely a bad idea. The new MDR does not allow for grandfathering meaning that products that are currently on the market will not automatically be approved to stay on the market. So, if you choose not to transition to the MDR your product will no longer be allowed on the European market and consequently, you will lose income in other countries where turnover is dependent on a valid CE-mark.


2. I’LL DO IT LATER


Tempting, but not a good idea either. To explain this, let’s have a look at the math. To be compliant with the new MDR there are activities that have certain throughput times.
For example, let us assume that your clinical evaluation gap analysis shows that you need to upgrade your clinical data with data from a Post-Marketing Clinical Follow-up study (PMCF). If we pivot these numbers against the time left until you lose your CE-mark, we come to the following:

Activities that would have to be performed against the time it would take and the time that is left in months.

All these activities alone leave you with ‘0‘ months left until your CE mark (read: market approval) expires if you aren’t compliant with the new requirements. So actually, we can say that every moment that companies are delaying the transition to the MDR they will be facing a loss of revenue from the marketed product.


3. START NOW


Yes, we agree. This does not mean that you will be overwhelmed by additional work that can’t be handled.
For instance, your strategy on extending clinical data can be considered via Post Marketing Surveillance while still under the MDD using a PMCF study to gather this data. Under the new MDR, this collection of clinical data without a CE-mark will be considered a clinical investigation, which is subject to far stricter requirements. In that case, you’ll have to set up, for instance, a new randomized controlled clinical study with a 100 patients, a 6-month patient follow-up, and at 10 different sites which is a very costly process with patient insurance, submittal to the Competent Authorities and longer timelines than a PMCF. And also for other issues, a pragmatic approach can often be chosen so that your product’s certification remains valid and continuity of sales is not hampered by regulatory issues.

ARGUMENTS & BUY-IN


We can assure you that securing buy-in from the decision makers and different stakeholders in your company is essential in situations like these. So to pave the way we’ve lined up some arguments to use in persuading that you need to start today.
Since it all usually comes down to commercial considerations, this is likely to be your strongest argument. Here are some examples to paraphrase the money issue:

  • Loss of revenue in all countries where turnover depends on a valid CE-mark
  • Correct expected projections beyond 2020
  • Losing business will eventually result in a loss of qualified staff
  • Increased investments will be required to make up to regain lost market share
  • Investors are very aware of the MDR and usually require a transition plan
  • The company’s reputation is at stake

TRANSITIONING


The implementation of the MDR or the transition, if you will, is most likely an extensive project. And this actual transition is something we’ll get back to in another blog. To put it shortly, all companies are strongly advised to come up with a comprehensive transition plan including:

  • Relevant differences
  • Risk Class Determination
  • Conformity Assessment Procedure
  • Top Management Awareness and Commitment
  • Implementation Plan
  • Assessment Partner
  • Product Documentation
  • Quality Management System
  • Post Market Activities and Reporting

In conclusion, although the deadline of May 2020 seems far away, it really is false security. To ensure continuous compliance of medical device products to the new legislation, i.e. the MDR, a swift start and a solid plan are necessary. This will bring peace of mind to any Medical Device company because business continuity is assured.


So instead of waiting around to see what the future holds, get started and find out where you’re at. And if you’d like some more specific information don’t hesitate to leave us a message.

Blog by: Nick Veringmeier - Xendo

20-11-2017
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#EMA: Welcome to the Netherlands

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

As a fast-growing company, we are ready to support all life sciences companies during the transition of the EMA from London to Amsterdam. With over 240 efficiently cooperating consultants (including QPs, QPPVs, and Auditors) in different fields of expertise, we’re able to offer our customers a complete palette of services. Especially our familiarity with The Netherlands’ Health Authority, the MEB-CBG, will prove to be an asset for all companies that require expertise regarding their upcoming Regulatory Affairs changes that this transition will bring about.

Please contact us to find out more.

14-11-2017
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#Xendo awarded for the third time in a row as FD Gazelle

Xendo was named an FD Gazelle 2017 again, meaning we belong to the fastest growing companies in the Netherlands for the third time in a row. 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:

Our clients increasingly know how to find us for our expertise and support in all phases of product development and we are very grateful for the trust they place in Xendo.

Based on this trust, we have been able to grow our organization from 60 to over 240 employees. We plan to further expand in the Netherlands as well as internationally and as such we are always open to getting into contact with new potential colleagues. Please visit our website to see an overview of our most recent vacancies.

14-11-2017
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#COMPLETE PV SYSTEM: READY IN 1 MONTH

Bringing new products to the market while managing all pharmacovigilance (PV) requirements within a reasonable timeframe can be challenging, especially now that the technical requirements of a PV system are becoming increasingly complex. Getting it right the first time will help you off to a good start.


A high-quality and cost-effective solution

This is exactly what we can provide you with regarding the necessary support. Our PV experts provide cost-effective solutions in compliance with all regulatory requirements while you focus on what matters to you: the quality and safety of your product.

To assist in achieving a fit-for-purpose PV system and to safeguard your responsibilities as a Marketing Authorisation Holder, we offer an end-to-end solution for small and medium-sized companies who are about to bring a product to the market in the EU and need a fully functional pharmacovigilance system. We can provide the planning, implementation, and maintenance of any or all of the essential parts of your PV system. The complete set-up of your global PV system can be realised in 1 month, which includes:


State-of-the-art Safety Database - Argus

Our dedicated case processing team makes use of the industry acclaimed standard Oracle Argus Safety Database for Adverse Event Management; including Safety Database Hosting & PV Query Tool. By applying a multi-tenant approach and lean processes with a focus on first-time-right we’re able to offer this software as part of a cost-effective solution.  And with this state-of-the-art database, line listings and reports for case processing can be generated independently of the size of a corporation.

Have a look at the schematic overview.


Other PV services

After setting up your basic PV system, we are also fully equipped to provide you with all other PV services like:


Xendo - A trusted advisor

So why Xendo? Taking your product to the market requires experience and solutions beyond pharmacovigilance. This is why we aim to offer a complete spectrum, including all the expertise you’ll need to be successful.

Introducing our palette of services that complements our pharmacovigilance department and sets us apart as a full-service provider:

With many, effectively cooperating consultants in different fields of expertise at your disposal, we’re able to offer you a complete package and peace of mind.

Please contact us to find out more!


10-11-2017
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#Posters ESGCT 2017

At the ESGCT 2017 conference, we presented two posters on CMC development and comparability strategies.  Afterwards, we received several requests for the posters and additional info, so we have decided to put them online! Have a look and leave us a message if you'd like more info as well.

Comparability Exercise

CMC Development

08-11-2017
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#BIO Europe Berlin

Xendo CEO André van de Sande and Xenia Freifrau-von Maltzan brought one of our customized VANMOOF bikes to this years' BIO Europe in Berlin. Several hundred participants showed that the raffle we organised with Berlin Partner was a huge success and attracted a large crowd. We wish to congratulate this years' winner and we are very much looking forward to another successful BIO again next year!

31-10-2017
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#Brexit: Picking a new Reference Member State. How?

In our previous Brexit blog we gave a broad overview of consequences that are on the horizon for the (bio)pharmaceutical industry. Especially professionals in Regulatory Affairs, Quality Assurance and Pharmacovigilance will be affected besides those working at EMA headquarters. Though nothing is certain yet we stipulated that, for the moment, the best advice may be to prepare for the worst: a hard Brexit. An important item on the list is to select a new Reference Member State (RMS).

Reference Member State

A reference member state is like a marriage; you stick with it for life; at least your product does. There are only two reasons to request a change of RMS. Usually, the Marketing Authorisation Holder (MAH) can request a change of RMS under exceptional circumstances, as described in the procedural advice by the CMDh. The other reason is (you probably saw this one coming) Brexit; or more specifically, the triggering of Article 50 by an RMS. To whom would this apply? All companies that have a marketed product for which the RMS for a Mutual Recognition Procedure (MRP) or Decentralised Procedure (DCP) is currently the UK. Seeing as how the UK is in second place (right after the Netherlands) for the total amount of new applications (MRP/DCP) and in third for finalized procedures (2017), a large number of companies will be affected.

Below you can see the new applications (started and finalised) from January 1st to June 30th this year as reported by the CMDh; click here for larger image.

So just a quick summary of an RMS’ role. They act as:

  • scientific assessor of a dossier
  • regulatory advisor to the applicant
  • moderator between applicant and CMS

The RMS provides regulatory and scientific advice as well as assessment reports, they decide on timetables, evaluate responses, organize and chair break-out sessions, refer to the CMDh, inform the EMA if there is no consensus after referral, inform applicant and Concerned Member State (CMS) after positive conclusion and prepare the final assessment report as well as the public assessment report.

It’s clear there’s ample motivation to do some research on the different Health Authorities (HA). What should you look for in a new RMS?? Some of the items to investigate prior to your selection could be.

Things to consider when picking a new RMS

Know your RMS

Previous experiences with an HA can be of major advantage. These connections often make sure procedures move along according to the set timetables without any unforeseen trouble because you understand their point of view, they speak the same language so to speak.  These professionals look out for and mitigate unforeseen delays due to their experience with that RMS; they are familiar with their workload, approach and the way they communicate.

Differences among Health Authorities

Although we’re all in the EU, every member state is responsible for their own day-to-day business. Though not limited to just Health Authorities, this is certainly the case here as well. Some might be better communicators, others more prone to act in a timely matter and others more inclined to be open to more pragmatic approaches. Companies are especially recommended to check the pass-through times and a backlog of a possible new RMS and are required to contact the Health Authority in advance to check their availability to take over as RMS for existing procedures. Besides there is also a difference in not every HA has extensive experience acting as an RMS at all.

It’s also worthwhile to see which of the current Member States are actively preparing for Brexit like the MEB in the Netherlands.

The Medicines Evaluation Board (MEB) is preparing for the partial takeover of extra work which arises due to Brexit. In this context continuity is paramount. For that reason, the Dutch government is investing € 2 million in extra capacity for the MEB in the coming years. Investments are also being made in reinforcing the European network by facilitating extra training opportunities.

 

Initiatives like these will most likely help assure a smooth transition to a new RMS.

RMS has experience in a therapeutic area

Some RMS have more experience than others in certain therapeutic areas. Are you a generic, you might want to check the originator’s RMS; which is often also the RMS for other generics. This is noticeable when an originator product goes off-patent because almost all generics manufacturers will tend to apply with this same RMS with which the original was registered. Or does a Health Authority have a special focus regarding specific therapeutic areas? Have they been involved in the development of certain guidelines? If the new RMS is going to be one of the current CMS, recall what the attitude towards the product was during a previous application. These are all questions worthwhile to investigate before making a final decision.

Location of the company

Though it might seem like an open door, avoiding language barriers and having the proper infrastructure in place is always a benefit to the daily business. As a matter of fact, the EMA itself is currently in the process of deciding on a new location for its headquarters (deadline 22nd November) and in a technical report by the agency they name several aspects that are deemed to be important factors weighing into the final decision.

It’s also strategic to choose your RMS according to your company’s EU affiliates; opening up the possibility of direct communication with the HA. Increased contact and the ease of face-to-face counsel can contribute positively. This is especially useful considering we’re working in a regulatory universe that seems to thrive mainly on communication through elaborate documents. Besides these advantages, it also allows affiliates to join the strategic conversation with HQ and to increase their visibility and experience.

Commercial reasons

Last but not least: financial gain. There are several commercial reasons to interact with a certain RMS; straight-forward aspects like fees charged by HAs, the market size of the RMS and are there key opinion leaders available?

Practicalities and recommendations

Some practicalities to keep in mind:

  • there can be no change of RMS during an ongoing procedure (of importance for timing/planning);
  • it is the obligation of the MAH to ensure that both the current RMS and the future RMS accept the change of RMS;
  • it is the responsibility of the MAH to supply to the new RMS if any dossier/ assessment reports or other relevant materials are missing or for any reason not already in possession of the new RMS.

And some summarizing recommendations:

  • an organisation should map their situation and set up reasonable timelines for the upcoming changes
  • budgets need to be adapted to higher (or lower) costs; HAs charge different fees for procedures
  • investigate possible RMS to your best ability or attract external advice
  • contact your HA of choice well in advance to prevent any unwelcome surprises

RMS overview

Finally, remember that these changes are imminent, possibly causing a rush on popular HA’s and thus proper planning is well-advised, to say the least.

Below you’ll find all possible member states that can be chosen as an RMS. There are, of course, differences in the amount and nature of applications these states have handled in the past and it would be far too elaborate to discuss all possible differences. So to this purpose, we’ve highlighted the ones that we’ve personally worked with up until today. Should you have any questions we invite you to contact us for some additional specific information.

And we always welcome any new topics regarding Brexit that you’d like to hear more about!

Blog by: Nick Veringmeier - Xendo

Austria

Belgium

Bulgaria

Croatia

Cyprus

Czech Republic

Germany

Denmark

Estonia

Spain

France

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Finland

Luxembourg

Malta

Netherlands, The

Poland

Portugal

Romania

Sweden

Slovakia

Slovenia

Iceland

Norway