Data Integrity

Data Integrity is an increasingly important topic in the Pharmaceutical Sector. Partly because it is on the agenda with the regulatory bodies and a topic for inspections, resulting in a significant number of observations, FDA Warning Letters and EU Non-Compliance Reports.   Specializing in Pharma and IT we have been assisting preparing for a Pre-Approval …

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Are we all done with Serialization after the EU implementation?

FMD Implementation Most companies in the pharmaceutical sector have their eyes on EU and have full speed on their FMD implementation. Every week, good news and progress are announced from different partners in the Supply Chain, and more and more countries are getting their national systems connected to the central database EMVO. This is all …

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Pharmacovigilance – Guidance on EU Risk Management Plans

In the EU, a Risk Management Plan (RMP) should be submitted as part of a Marketing Authorisation Application by the Marketing Authorisation Applicant (MAA). It should also be submitted for marketed products by the Marketing Authorisation Holder (MAH) in case of major updates affecting the benefit-risk balance or by request from EMA or a national …

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Why should small and medium size Pharmaceutical and Biotech Companies outsource their Data Protection Officer?

The EU General Data Protection Regulation will become effective on the 25th of May 2018. As outlined below the Data Protection Officer (DPO) position will most likely be a part time position in small and medium size Pharmaceutical and Biotech Companies. The DPO position will not be in line with the company’s core capabilities and it could be difficult …

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Pharma IT Services

Pharma IT focus on delivering services and consultancy related to business and IT within the Pharmaceutical Industry. We focus on quality and set high standards for ourselves. Our identity is to be agile and competitive, we only engage with the best – our consultants are skilled and professional, having many years of experience within Pharma and …

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Pharma IT expands with another experienced IT Project Manager

Pharma IT is happy to announce that Mogens Høgh from February 2016 whave made an agreement with Pharma IT. Mogens is a Senior IT Project Manager and have more than 16 years of experience within the Pharmacutical Industry. Mogens has already been assigned to support one of the large Pharmaceutical Companies in the Copenhagen area as an IT Project Manager. Pharma IT is still looking …

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Iperion and Pharma IT announce partnership in the delivery of full cycle IDMP services for the pharmaceutical industry

Iperion, a leading provider of consultancy services, information systems and IT services-GxP cloud computing for the life sciences industry, and Pharma IT, a provider of IT services and business consultancy announces a partnership to deliver quality IDMP consulting services for the pharmaceutical industry. “We are excited about the partnership between Pharma IT and Iperion, says Frits …

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Pharma IT hires new Quality and Compliance Consultant

Pharma IT is happy to announce that Stine Kristensen from  2016 will join Pharma IT as a Senior Pharma Consultant. Stine has more than 10 years of experience within the Pharmacutical Industry and is specialised within Quality and Compliance consulting. Stine has already been assigned to a Compliance Consulting task for one of the large Pharmaceutical Companies in the Copenhagen area. …

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