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Services during project development

  • Development and drafting of the full application of drug registration dossiers
  • Management of registration dossier submission in electronic format (Nees and Vnees)
  • Development and drafting of the part concerning administrative data, Summary of Characteristics and package leaflet.
  • Experts reports about chemistry-pharmaceutics, pharmacology-toxicology and clinics (tabular and summary)
  • Coordination of each and every one of the experimental studies that make up the project
  • Documentation management of the studies to be carried out
  • Development, drafting and management of the documentation for the clarifications requested by the Spanish Drug Agency
  • Conducting the necessary studies to demonstrate the quality, safety and efficiency of the drug in question

Customers

Our services are aimed at the chemical-pharmaceutical business sector, i.e.

  • The pharmaceutical industry
  • The veterinary industry
  • The cosmetic industry
  • The phytotherapy industry
  • The medical device industry
  • The food industry

Team

  • Personnel with a higher technical qualification and over 20 years’ experience in the pharmaceutical industry:
  • Drug registration dossier management and development
  • Implementation of quality systems (GMPs and ISO)

Our values

  • Service
  • Excellence
  • Independence
  • Teamwork
  • Commitment
  • Profitability

Our company

LOUFARM is an independent technical consultancy whose staff consists of recognized professionals with extensive experience in the field of health, especially in the field of animal health and veterinary medicines.

Copyright © Loufarm. Todos los derechos reservados.
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