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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Other services

 

Regulatory Affairs

Through the cooperation with Ivowen Ltd., Quinta-Analytica offers expert advice on Regulatory Affairs and Project Management to the generic pharmaceutical industry.

We bring an expertise to the analytical problems in GMP, GLP and GCP environment but also can provide regulatory affairs support as consultants to pharmaceutical companies based in the European Union, in EU accession states and worldwide on the successful development and timely registration of their products in the EU and other markets.

Cooperation with Ivowen Ltd. enables the following services:

  • Project and/or Study Management
  • Abridged Applications
  • National Procedures, Mutual Recognition and Decentralized Procedures
  • Variations, Renewals
  • Certificates of Suitability
  • Regulatory Strategy