Pharmaffect BV is a leading pharmaceutical consultancy service office, active for more than 10 years on the European market. Pharmaffect offers a broad range of pharma and medical devices related consultancy service.
Pharmaffect is founded in 2006 by Wouter van Berckel.
Wouter graduated at the State University of Utrecht in 1997 as a pharmacist.
In his year of graduation Wouter started his working career at consultancy firm BFC. In the 7 years he worked for this company he supported many pharma companies in a broad portfolio of products and services. In 2005 Wouter switched to LLOYDS pharmacies (CELESIO group) as manager healthcare insurers and as such he was in the forefront of the new roles and responsibilities in the new healthcare market which started in 2006. The team was very successful in negotiating long term contracts with healthcare insurers.
In the summer of 2007, Wouter started working in a new role as Business Development Manager/ Responsible Person for DHL Exel Supply Chain. As such he had both a senior quality role as well as a senior relationship and acquisition business development role.
Starting in 2006 his own business, next to his permanent roles Wouter was increasingly asked for support in all kinds of quality and regulatory affairs assignments. Finally he decided to make this a full time occupancy in September 2008.
Wouter founded Pharmaffect to offer specialised support in pharma licensing, production, distribution, pharma logistics and regulatory affairs, but Wouter wants to be unique, in combining all of these expertises and experiences. Where in pharma industry many specialised functions are in place in parallel, Wouter wants to add value in building bridges amongst these specialisations. His overview of strategic challenges with a hawk eye from different angles is a trusted asset of Wouter.
Wouter is able to assist with a variety of services, like Quality Affairs, Regulatory Affairs, Market Access, Auditing, Strategic advice, Pharma Logistics, Business Development, license applications for pharmaceutical manufacturer, wholesaler, narcotics, creation or update of Quality Management Systems.
Wouter has supported many companies with the application, holding and maintaince of manufacturer's, wholesaler's and narcotics licenses and act as the legal mandatory "Responsible' and 'Qualified' Person. From generics to biotech, Wouter has made crossectional steps in the pharmaceutical for more than 18 years.
With the increased emphasis of legislators on a closed quality chain of pharma and meddev supply, Wouter can give specific advices on requirements and compliance to correct logistical handling. GDP audits are amongst the vast experience of Wouter.
A never-ending list of companies have hired Wouter to exploit its knowledge and services: Pfizer, Teva, Vifor, Merz, Allergan, Abbvie, Medical Export Group, Novartis, GSK, Medtronic, Amstelfarma, Bracco, Johnson and Johnson, Abbott, Actavis, Fresenius, Procter & Gamble, Air Liquide, Almirall, Galderma, etc. Besides that Wouter serves an ambassadorship for GS1.
Wouter is able to assist with all Quality Affairs related projects, like GMP and GDP optimization, GDP/ GMP auditing, license applications for pharmaceutical manufacturer, wholesaler, narcotics, creation or update of Quality Management Systems. Regulatory Affairs is a service provided by Wouter for more than 20 years, already. Do you need a general assessment of your dossier or system or a detailed analysis?
Regulatory Affairs is a service provided by Wouter for more than 20 years, already. Do you need a general assessment of your dossier or system or a detailed analysis? Do you need to submit a full dossier or need temporary support in RA Maintenance? Wouter has knowledge of the procedures and systems, like MRP/DCP/ Trackwise, Documentum, CESP, Artwork Generation.