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Vigilex - Introduction to Vigilex

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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Vigilex - Introduction to Vigilex | vigilex.com Reviews

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As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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1 career

2 about us

3 team

4 services

5 adverse event management

6 periodic reports

7 safety procedures

8 audits

9 qppv

10 consultancy

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Vigilex - Introduction to Vigilex | vigilex.com Reviews

https://vigilex.com

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

INTERNAL PAGES

vigilex.com

1

Vigilex - QPPV

http://www.vigilex.com/en-624/qppv-.htm

Sandra van der Poel - Smet. T: 31 (0)71 524 40 00. In the EEA, Marketing Authorisation Holders are required to appoint a QPPV and a deputy QPPV residing in the EEA. Selected senior Vigilex staff are able to take on these extremely demanding roles and are fully aware of the considerable responsibilities involved. A detailed description of the respective tasks and responsibilities of the MAH and the QPPV will be included in the agreement, allowing each party to effectively perform their respective roles.

2

Vigilex - Adverse Event Management

http://www.vigilex.com/en-631/adverse-event-management-.htm

T: 31 (0)71 524 40 00. Vigilex is able to manage part or all of the processing phases of Adverse Events from clinical trials and post-authorisation sources: triage, data entry, quality control, MedDRA coding, medical review, reportability assessment, submission (gateway or paper) and follow-up. Well-trained staff are familiar with global safety databases routinely used by pharmaceutical companies. Vigilex 31(0)71 524 4000 mail@vigilex.com.

3

Vigilex - Team

http://www.vigilex.com/en-635/team.htm

The Vigilex Group relies on an enthusiastic team of dedicated professionals with international, hands-on pharmacovigilance experience. Our pharmacovigilance staff typically have a medical, pharmaceutical, life sciences or registered nursing background. Their up-to-date knowledge and expertise, supported by ongoing training, guarantee consistently high-quality services for an ever-increasing number of clients. Vigilex 31(0)71 524 4000 mail@vigilex.com.

4

Vigilex - Inspection Preparedness

http://www.vigilex.com/en-613/inspection-preparedness-.htm

Sandra van der Poel - Smet. T: 31 (0)71 524 40 00. Over the past years, competent authorities have increased and intensified their regulatory inspections. As support to clients during their preparation for these inspections, Vigilex has developed proven concept for inspection preparedness training. This training is usually conducted in-house and aims to ensure that staff are aware what is expected during interviews and how to conduct themselves during an inspection.

5

Vigilex - Consultancy

http://www.vigilex.com/en-616/consultancy-.htm

Sandra van der Poel - Smet. T: 31 (0)71 524 40 00. Vigilex senior staff strive for excellence in their consulting activities. Their common denominator is how to make all advice work well in practice so that clients get value for money. Internally, Vigilex will allocate a consulting assignment to a senior member of staff depending on the required background and expertise. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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xendo.com

Xendo - Mission & Vision

http://www.xendo.com/en-66/mission-vision-.htm

Engineering and Technical support. Xendo makes the Dutch Financial Times (Financieel Dagblad) again! Xendo announces management buy-out supported by Sovereign Capital. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. New Director Regulatory Affairs. Xendo at the CPhl/P-MEC 2014 in Paris. Recent publication of EMA about updating regulatory information on authorized medicines *).

xendo.info

Xendo - Diensten

http://www.xendo.info/nl-3/diensten.htm

Engineering and Technical Support. Xendo haalt wederom het Financieel Dagblad! Xendo announces management buy-out supported by Sovereign Capital. Hans Dalderop van TEVA als spreker bij Innovation for Health. Xendo Premium Sponsor: Innovation for Health. Technology for Health 2015. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. Nieuwe directeur Regulatory Affairs. Winnaar BCF Career Event.

xendo.nl

Xendo - Welkom op de Xendo website

http://www.xendo.nl/nl-1/home.htm

Engineering and Technical Support. Xendo haalt wederom het Financieel Dagblad! Xendo announces management buy-out supported by Sovereign Capital. Hans Dalderop van TEVA als spreker bij Innovation for Health. Xendo Premium Sponsor: Innovation for Health. Technology for Health 2015. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. Nieuwe directeur Regulatory Affairs. Winnaar BCF Career Event.

xendo.nl

Xendo - Laboratoria

http://www.xendo.nl/nl-476/laboratoria.htm

Engineering and Technical Support. Xendo haalt wederom het Financieel Dagblad! Xendo announces management buy-out supported by Sovereign Capital. Hans Dalderop van TEVA als spreker bij Innovation for Health. Xendo Premium Sponsor: Innovation for Health. Technology for Health 2015. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. Nieuwe directeur Regulatory Affairs. Winnaar BCF Career Event.

xendo.nl

Xendo - Kwaliteit

http://www.xendo.nl/nl-206/kwaliteit.htm

Engineering and Technical Support. Xendo haalt wederom het Financieel Dagblad! Xendo announces management buy-out supported by Sovereign Capital. Hans Dalderop van TEVA als spreker bij Innovation for Health. Xendo Premium Sponsor: Innovation for Health. Technology for Health 2015. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. Nieuwe directeur Regulatory Affairs. Winnaar BCF Career Event.

xendo.com

Xendo - Willkommen auf der Xendo Webseite

http://www.xendo.com/du-401/home.htm

Engineering and technical support. Xendo hebt Maintenance Management auf andere Level. Willkommen auf der Xendo Webseite. Xendo ist ein führendes, unabhängiges Unternehmen für Beratung und Projektmanagement in den Bereichen Life Sciences, Arzneimittel und Gesundheitswesen. Wir werden Sie bei der Verbesserung der Qualität und Sicherheit von Medikamenten sowie bei der Beschleunigung des Markteintritts unterstützen. Launch of the Regfee calculator. Here is the link to the calculator:. In your company you&rs...

xendo.info

Xendo - Ziekenhuizen

http://www.xendo.info/nl-475/ziekenhuizen.htm

Engineering and Technical Support. Xendo haalt wederom het Financieel Dagblad! Xendo announces management buy-out supported by Sovereign Capital. Hans Dalderop van TEVA als spreker bij Innovation for Health. Xendo Premium Sponsor: Innovation for Health. Technology for Health 2015. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. Nieuwe directeur Regulatory Affairs. Winnaar BCF Career Event.

xendo.info

Xendo - Medische Hulpmiddelen

http://www.xendo.info/nl-474/medische-hulpmiddelen.htm

Engineering and Technical Support. Xendo haalt wederom het Financieel Dagblad! Xendo announces management buy-out supported by Sovereign Capital. Hans Dalderop van TEVA als spreker bij Innovation for Health. Xendo Premium Sponsor: Innovation for Health. Technology for Health 2015. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. Nieuwe directeur Regulatory Affairs. Winnaar BCF Career Event.

xendo.info

Xendo - Willkommen auf der Xendo Webseite

http://www.xendo.info/du-401/home.htm

Engineering and technical support. Xendo hebt Maintenance Management auf andere Level. Willkommen auf der Xendo Webseite. Xendo ist ein führendes, unabhängiges Unternehmen für Beratung und Projektmanagement in den Bereichen Life Sciences, Arzneimittel und Gesundheitswesen. Wir werden Sie bei der Verbesserung der Qualität und Sicherheit von Medikamenten sowie bei der Beschleunigung des Markteintritts unterstützen. Launch of the Regfee calculator. Here is the link to the calculator:. In your company you&rs...

xendo.com

Xendo - Business Areas

http://www.xendo.com/en-309/business-areas.htm

Engineering and Technical support. Xendo makes the Dutch Financial Times (Financieel Dagblad) again! Xendo announces management buy-out supported by Sovereign Capital. GMP for excipients: manufacturing authorization holders expected to take action. Xendo Acquires Brinker Pharmaconsulting. Xendo awarded for FROM IDEA TO CE concept. New Director Regulatory Affairs. Xendo at the CPhl/P-MEC 2014 in Paris. Recent publication of EMA about updating regulatory information on authorized medicines *).

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Vigilex - Introduction to Vigilex

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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Vigilex - Explosion vent panels

VIGILEX explosion vent panels are designed by the STIF. Company, which is specialized in the manufacture of components for the bulk handling industry. Created in 1984, the S.T.I.F. Product manager protection and explosion. SEE ALL THE RANGE OF PANELS Of EXPLOSION. SEE ALL THE RANGE FLAME ARRESTOR. Thermal insulation, weather protection, mounting frames, vaccum safety grid . Accessories for panels of explosion. Accessories for Flame arrestor. Questions for sizing of explosion panels. Data sheet VIGILEX MEC.

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Vigilex - Introduction to Vigilex

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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