QualitecFarma
Contact information
QualitecFarma, SL
Óscar Mesa
Musgo, 2
Madrid
Madrid
913728399
Areas of activities
- D. Services
- R&D services
- CRO / CMO / SMO
- Professional services
- Consultancy
Commissions
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