Xendo
Xendo is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices and healthcare. Thru their multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects they participate in. For over 25 years the company have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Over 220 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.
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| | |
| Type | Private |
| Founded | 1990 |
| Headquarters | Leiden, ZH |
| Key people | ANDRÉ VAN DE SANDE
MSC MBA - CEO |
| Number of employees | 51-200 employees |
Contents
History
1990 - Eurovalid is founded in Amsterdam, providing compliance and validation services to the pharmaceutical industry.
1995 - Eurovalid is incorporated into Eurovalid B.V.
1996 - Arthemius v.o.f. was founded, to bring additional expertise for biotechnology sector.
1997 - Eurovalid B.V. and Arthemius v.o.f. internally merge to form Eurovalid-Arthemius B.V.
1998 - Helix Engineering B.V. starts collaboration with Eurovalid-Arthemius B.V. to expand the range of services with pharmaceutical engineering. New activities are employed by starting VipQuip B.V.,delivering management and business development services to the (bio)pharmaceutical industries, teams up.
1999 - Xendo Laboratories B.V., a bioanalytical contract laboratory is founded in Groningen.
2000 - The company headquarters move from Amsterdam to the Bio Science Park Leiden. Univalid Holding B.V. becomes the umbrella company over all operating companies. The names of the different operating companies in Leiden are uniformed. Eurovalid-Arthemius B.V. changes to Univalid Compliance and Validation B.V. Helix Engineering B.V. changes to Univalid Engineering B.V. Probion B.V. changes to Univalid Management and Development B.V. Vipquip B.V. changes to Univalid Metrology B.V.Xendo Laboratories B.V. although part of Univalid Holding B.V. keep its name.
2002 - Univalid Holding B.V. acquires a part of Bird Engineering B.V. to form Univalid Bioprocessing B.V.
2004 - Xendo Drug Development B.V. expands with Xendo Clinics B.V.,a 12-bed Clinical Pharmacology Unit for phase I/IIa clinical research, and Xendo Pharma Design B.V., a consultancy firm focusing on strategic drug research and development, both on the premises of the University Medical Centre Groningen.
Xendo Drug Development B.V., a 100% subsidiary of Univalid Holding B.V., is founded in Groningen, to hold Xendo Laboratories B.V.
Quality Engineering, a business unit of Univalid Engineering B.V. internally merges with Univalid Metrology B.V. to form Univalid Technical Support B.V.
Univalid Bioprocessing B.V. moves its research and pilot laboratories from Delft University to the Bio Science Park in Leiden.
2005 - Xendo Clinics B.V. opensa second 14-bed Clinical Pharmacology Unit for phase I/IIa clinical research on the premises of the University Medical Centre Groningen.
2006 - As of January 1, 2006, Univalid Holding B.V. has been restructured and renamed Xendo B.V. Xendo employs close to 200 people and is comprised of three operational divisions:
Xendo Drug Development B.V.
Xendo Manufacturing B.V.
Xendo Pharma Services B.V.
2007 - Xendo B.V. forms a joint venture with the University Medical Center Groningeb. The joint venture, Xendo Clinical Trial Material, will produce drug candidates on small scale according to Good Manufacturing Practices.
2008 - The Groningen site expands its clinical research portfolio offering (temporary) contract research services in support of phase II-IV studies with drug and medical device candidates. These services are offered through a new division named Xendo Clinical Research.
2009 - The Leiden site realigns its structure to better serve our customers. Three divisions were formed, creating a maximal synergy:
Xendo Manufacturing
Xendo Pharma Services
Xendo Regulatory Affairs
Xendo establishes Xendo Deutschland in Berlin, to better meet the needs of German customers. Focus of the German services are on regulatory affairs for drugs and medical devices, from initial set-up to maintenance of dossiers.
2010 - As per July 2010, Xendo Drug Development has been acquired by QPS (an international CRO). The Xendo consultancy and manufacturing activities continue under the name Xendo.
2011 - Xendo BV and Batavia Bioservices BV have initiated a strategic business collaboration. As a consequence, all Bioprocess activities of Xendo Manufacturing BV have been transferred to Batavia Bioservices BV. Through this collaboration Xendo can continue to offer Bioprocessing services.
2013 - Xendo BV has acquired the Vigilex Group allowing Xendo BV to further expand its palette of services with pharmacovigilance activities and at the same time have new branches in the United Kingdom and Japan.
2015 - Xendo has acquired Brinker Pharma GmbH allowing Xendo to further expand its presence in the German market offering the full range of consultancy services.
2016 - Sovereign Capital, the UK private equity Buy & Build specialist, has completed the management buy-out of Xendo BV. Sovereign has partnered the management team to further develop the business through a strategy of organic and acquisitive growth.
2017- Xendo has acquired the Swedish consultancy company Sofus Regulatory Affairs AB. Sofus is based in Stockholm and provides regulatory affairs services for all phased 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.
Services Offered
- Regulatory Affairs
- Engineering & Facility Support
- Product Development - offers industry seasoned CMC project managers and over 100 pharma and biotech professionals in biological sciences, and small molecule development. We cover the areas of manufacturing, analytics, quality assurance, engineering and regulatory affairs. has experience with the development of MAbs, recombinant proteins, vaccines, gene and cell therapy products, and small molecules. We can provide you with a product development roadmap and successfully guide your product development to Clinical and to the market. Also for your medical device we can manage the design process and apply the required design controls, thereby creating a solid Design History File / Medical Device File and paving the road for a successful regulatory submission.
- Quality Management & Lean Sigma
- Qualification & Validation
- Pharmacovigilance
Pharmacovigilance
Understanding pharmacovigilance regulations and requirements, access to a wide range of services, and a senior expert team are repeatedly highlighted as essential criteria when clients select Xendo Pharmacovigilance as their flexible service provider. Working globally, they understand international requirements. Being consistently quality driven and customer focused has led to a proven track record of meeting or exceeding clients` expectations. They are also regularly asked to lecture or moderate at international seminars and symposia as experts in the field.
From the outset, they have been a full-service provider for pharmacovigilance. Due to a sound Quality Management System they ensure that all activities conducted for and on behalf of clients are in line with applicable standards.
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References
https://www.linkedin.com/company-beta/97446/ https://www.xendo.com/company
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