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Contact information

QualitecFarma, SL
Óscar Mesa
Musgo, 2
Areas of activities
  • D. Services
    • R&D services
      • CRO / CMO / SMO
    • Professional services
      • Consultancy

Clinical development of new medicines and different therapeutical areas from start-ups to big pharma companies and public research projects, spin-offs or R&D foundations.

  • Promotion of the clinical research in Spain
  • Entrepeneur financiation fundraising
  • International regulatory process on medicines, medical devices, food supplements and cosmetics.
  • Pharmacovigilance
  • Regulatory due diligence
Products and services
  • Clinical Trials Phase I to IV, observational and epidemiological
  • Investigators clinical trials
  • Clinical Development Plan, trial protocols development, IB and IMPD
  • Study Design and background for protocol.
  • CTA regulatory submission to EC and HA
  • Bioestatistics and data management, eCRD.
  • Launch and mantainance of the TMF
  • Clinical Quality and centres audit.
  • Clinical viability evaluation.
  • Preclinical Trials and Toxiciology, ERAs.
  • Fundraising projects for start ups.
  • Good Clinical Practices (GCPs)
  • Finished dose form Registration dosseir compilation eCTD.
  • Regulatory viability evaluation.
  • Regulatory due diligence in mergers and acquisitions.
  • Licensing in out
  • MA regulatory authorisations worldwide
  • Regulatory gap analysis
  • Variations to MA conditions
  • Regulatory Intelligence
  • regulatory establishment of new pharma companies in the territory MAH approval.
  • Pharmacovigilance system, eu-QPPV, certified system by Health Authorities according to GVPs
  • certified quality system ISO9001/2015 by AENOR-IQNET