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Regulatory Affairs Services

ZEINCRO’s regulatory team is comprised of experts experienced in all regulatory issues. We provide a wide range of regulatory affairs services, including pricing and reimbursement, to our clients. We focus on the client’s needs and requirements, to provide services of high quality that meet their expectations.

 

Flexibility, experience in multidisciplinary projects, excellent relations with Health Authorities and deep knowledge of legislation and regulatory environment are the major strengths of our department.

 

The regulatory affairs department of ZEINCRO offers a wide range of services to its clients summarized below:

  • Μarketing Authorisation Applications (Decentralised Procedure, Mutual Recognition Procedure, National Procedure).
  • Activities to comply with local requirements following Centralised Procedures.
  • Maintenance of the Marketing Authorisations, Variations and Renewals.
  • Transfers of Marketing Authorisations.
  • Pricing and Reimbursement applications and consultancy
  • Regulatory review of packaging material
  • Regulatory review of promotional material and consultancy on compliance of promotional activities
  • On-site placement of regulatory staff according to the client’s needs.
  • Effective collaboration with the authorities and intensive follow-up in every submission, in order to ensure timely conclusion of the national phase of the procedures.
  • High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet to the local language.
  • Consultancy services concerning the local regulatory provisions and requirements.
  • Notifications/Registrations and consultancy services for medical devices, food supplements, cosmetics, and biocides.
  • Training in Regulatory Affairs
Interest Form

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  • Interventional Trials - Phase I - IV
    Non Interventional Trials - Post Authorization Safety and Efficacy Studies
    Regulatory Affairs
    Pharmacovigilance
    Other
     
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ABOUT US

ZEINCRO is a leading contract research organization covering more than 21 countries in Europe, with a special focus in the region of Central and South Eastern Europe (Albania, Austria, Bulgaria, Cyprus, Czech Republic, Germany, Estonia, FYROM, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, the Netherlands, Poland, Romania, Slovakia, Switzerland, Turkey and Ukraine).

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CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

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