Drug safety for animals and humans

Extensive measures apply to the product lifecycle of medicinal products in veterinary and human medicine. These obligations are specifically designed to ensure an optimal benefit/risk-profile of the products when used for and by the patients.

Dr. Vladislav Kurtev is your contractor for marketing authorisation, drug safety, pharmaceutical lifecycle-management and medical writing.

Understanding your business needs, Dr. Vladislav Kurtev will identify the most appropriate services necessary to meet the desired outcome of your project. This can include the following services.

1

Marketing authorisation (Regulatory Affairs)

  • Support for marketing authorisation applications in all phases of the procedure
  • Data compilation and evaluation
  • Preparation and revision of information materials, Summary of Product Characteristics (SmPC), package leaflets and labelling
  • Definition of optimal regulatory strategies for marketing authorisation and variation applications

2

Drug safety (Pharmacovigilance)

  • Case management
  • Expedited reporting - Eudravigilance
  • Preparation of periodic reports
  • System oversight und performance monitoring
  • Pharmacovigilance system conception and implementation
  • QPPV function (Qualified Person for Pharmacovigilance)

3

Medical Writing

  • Authoring of educational materials
  • Preparation of study documents for clinical trials
  • Processing of clinical and scientific data and information

This is what my partners say

DI Hannes Sachsenhofer

General Manager

Adliance

„We highly value Dr. Kurtev’s work. His expertise and experience are invaluable for the development of our pharmacovigilance software. Open communication style, pragmatic and solution-oriented approach – we couldn’t hope for a better cooperation.“

Dr. Bernd Follrich

Business Unit Manager

Richter Pharma Development

„Broad expert knowledge, thinking in solutions, adherence to schedules, interpersonal skills and enthusiasm for completion are what Dr. Kurtev has on offer and what constitutes the basis of our cooperation. Creative and pragmatic solutions are translated into concrete structures and generate possibilities which have often been of high value for us. As customers we feel that we are optimally serviced and are in the best hands.”

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