New pharmacovigilance legislation has meant companies must continually be vigilant or find trusted partners to help them respond to the changes
Cambridge, UK – June 12, 2014 – On June 14, life sciences outsourcing and consulting services specialist ProductLife Group (PLG) will celebrate the 40th anniversary of its recently acquired German regulatory and pharmacovigilance services provider business, Kohne Pharma GmbH.
During Kohne Pharma’s four decades in business, the company has seen huge market change. Judith Jech, General Manager at Kohne Pharma, believes the business’s enduring success is down to the foresight of the business to adapt to the changing needs of its customers, and to the calibre of Kohne’s people.
“Over the past few years, pharmaceutical companies have had to deal with increasingly tough regulatory requirements and additional pressure from the authorities to monitor medicinal products more closely,” she says. “New pharmacovigilance legislation has meant companies must continually be vigilant or find trusted partners to help them respond to the changes. That’s where I believe we have excelled.
“Around me I see a highly qualified team of regulatory and safety experts - people our clients would rate as excellent in their fields. Our clients trust us because our team of experts have demonstrated their insights and skills on so many occasions and over many years. Many of our employees have been with us for 20 years. As a result they’ve built strong relationships with clients, who know they can turn to our regulatory and pharmacovigilance team members for insight and guidance.”
Like most pharma service providers, Kohne Pharma has faced its fair share of challenges over the years as market dynamics have changed, Judith Jech adds. “These have required us to adapt and evolve – moving from the brokerage of German marketing authorisations and filing of national application procedures, to a business model today that is based around a whole portfolio of sophisticated services which directly address our clients’ priorities today.”
Becoming part of PLG is the latest exciting chapter in the company’s history, she says. “This has not only broadened the opportunities for Kohne Pharma, but gives our clients access to services in many other European markets. It puts a very positive spin on our 40th anniversary. We are proud that Kohne has achieved this landmark anniversary, and that by becoming part of PLG we have been able to deliver stability and continuity to our clients and employees.”
Commenting on Kohne Pharma’s milestone anniversary, PLG Chairman and CEO Pierre Cuny, says, “Kohne Pharma continues to go from strength to strength and is already a valued member of ProductLife Group. Our congratulations go to the management team which have spearheaded such a successful evolution over the last four decades. We look forward to the joint opportunities the next decade will bring.”
Kohne Pharma is a full-service company specialising in the sale of marketing authorisations as well as in regulatory affairs. Its areas of specialisation include Regulatory Affairs, Pharmacovigilance, eCTD and Quality Assurance Services, and corresponding Training. Today the business is known as “Kohne Pharma a ProductLife Group Company”.
About ProductLife Group
ProductLife Group is the leading, proven and trusted European-based specialist outsourcing services provider for the regulatory, safety and quality functions of the life sciences industry.
Through the optimum deployment of people and intellectual assets we enable our clients to achieve greater R&D effectiveness; significant cost reduction in capital and revenue terms; and improved operational speed and efficiency at the highest quality
These performance-enhancing improvements are delivered through a blend of the highest quality people and services comprising In-sourcing, Functional outsourcing, Strategic Business Process Outsourcing and Consultancy based on deep domain expertise and thought leadership.
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About Kohne Pharma GmbH
Based in Haan, near Dusseldorf in Germany, Kohne Pharma GmbH is a specialist in regulatory affairs with a track record of 40 years of providing a full range of services to the life sciences industry in its home market. These range from German application procedures to MR- and DC procedures within the EEA. Kohne is an expert in pharmacovigilance, and can manage the end-to-end planning and realisation of labour-intensive application procedures on companies’ behalf. It also provides support in the maintenance of marketing authorisations in a continually changing regulatory environment. Furthermore, Kohne Pharma sell development projects, dossiers, ongoing registration procedures and granted marketing authorisations of Generics.
Sarum PR – PR for Product Life Group
+44 1722 322916. Paul@sarumpr.com
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