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Advisory Services in Regulatory Affairs

  • Overall Project Planning (veterinary or human drugs), in accordance with current regulations
  • Regulatory strategy in product development
  • Product Overview: Study of the market and possible patents
  • Dealing with the Regulatory Agencies: Representation and dialogue with the regulatory authorities
  • Submission of Registration dossiers (electronically): Application for marketing authorization from the regulatory authorities
  • Updating the Registration Dossier: Variations of the conditions of authorization, Approvals, Renewals, Pharmacovigilance (postmarketing studies)
  • Drafting of the Drug Master File of active ingredients: preparation and presentation thereof
  • Expert Reports and tabular formats
  • Training
  • Scientific and technical audit:

 - Of the Registration dossier: compliance at all times with current legislation
 - Expert Reports and tabular formats

LOUFARM manages any transaction with the Regulatory Agencies (national, European or extra-community)


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


  • 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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