Chiesi relies on QUMAS to manage documentation for Regulatory Submissions

CORK, IRELAND - March 16, 2010 - QUMAS, a leading provider of regulatory compliance solutions, today announced that Chiesi, an international research-focused group dedicated to developing innovative pharmaceutical solutions has selected QUMAS DocCompliance™ as its enterprise regulatory content management solution. With QUMAS, Chiesi now has a single solution deployed across the Research and Development groups based in Italy, France, and the US that manages all of the documentation required for regulatory submissions.

"QUMAS was able to deliver an off-the-shelf compliance content management solution that is configurable to meet all our requirements," said Marco Alberici, Project Manager, Corporate Drug Development at Chiesi. "The QUMAS solution enables us to improve our time to market and to provide the regulators with better quality submissions, ensuring timely approvals."

Since the implementation of the QUMAS solution, Chiesi has successfully submitted the following applications:

  • An eCTD for a new pharmaceutical combination for inhalation in three European Countries - Belgium, the Netherlands and the UK
  • Variation in eCTD format of a Notice to Applicants submission
  • Variation in eCTD format of a CTD submission and a variation in eCTD format for an eCTD submission
  • Corporate Regulatory Affairs in Italy prepares eCTD Modules 1 to 5 for the Netherlands, Belgium, United Kingdom, Spain and EMEA

"Preparing applications manually increases the time-to-market for new products and tightens the profit window before patents expire," said Ken Hayward, Executive Vice President for QUMAS. "With QUMAS, Chiesi has deployed an automated solution that helps bring new products to market faster resulting in better bottom line performance."


QUMAS is the leader in Enterprise Regulatory Compliance Solutions with more than 250 customer deployments and over a decade of experience helping companies in highly regulated industries provide a proactive regulatory defense.

QUMAS solutions for life sciences are designed to achieve compliance with industry and government standards for 21 CFR Part 11, cGxP, Quality, R&D, Regulatory Affairs and Clinical Operations. QUMAS enables organizations to bring new drugs to market faster with better quality submissions while proactively managing regulated content and controls, reducing costs, and improving customer satisfaction. 

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About Chiesi Farmaceutici S.p.A.

Founded in Parma, Italy in 1935, Chiesi Farmaceutici S.p.A. has today reached international levels within the pharmaceutical sector in 5 continents with 22 direct affiliates, three manufacturing plants and three research centres.

The company employs over 3,000 people worldwide. In the three Research & Development centres (Italy, France and the U.S.), the workforce totals over 300 researchers, whilst those in production (Italy, France and Brazil) total around 550 people.

Strategic alliances at both global and local level, with international pharmaceutical groups ensure that Chiesi drugs and technology are available in over 50 countries.

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