REVIO PHARMACEUTICAL CONSULTANTS

Logo Revio

Información de contacto

Revio Pharmaceutical Consultants, S.L.U
Maria Antonia Reviriego Morcuende
Manolo Viola, 37, Bloque Bis, planta baja, puerta A
San Lorenzo de El Escorial
Madrid
+34 656 65 93 36
Áreas de actividad
  • Biofármacos
  • Biomarcadores
  • Células madre
  • Cultivos celulares
  • Drug development
  • Screening
  • Terapia celular
  • Terapia génica
  • Terapia tisular y biomateriales
  • Transplante
  • Consultoría
  • Mantenimiento de cultivos celulares

MISIÓN

Nuestra misión y pasión es trabajar para nuestros clientes y combinar nuestra experiencia e innovación para avanzar en su éxito en la prevención y curación de enfermedades.

 

VISIÓN

REVIO PHARMACEUTICAL CONSULTANTS aspira a ser el principal proveedor de asesoramiento regulatorio para empresas biofarmacéuticas para el desarrollo y registro de medicamentos innovadores como ATMP.

 

NUESTROS VALORES

  • INTEGRIDAD.
  • CALIDAD.
  • COMPROMISO.
  • FLEXIBILIDAD.
  • PASION.
Productos y servicios

Regulatory strategy and submissions

  • Regulatory Strategy and Roadmaps
    • Product development planning and execution
    • Long-term project management
    • Regulatory pathway
    • Gap analysis
    • Due diligence: inlicence and outlicence
  • Regulatory Preparation & Submissions
    • Clinical Trial Applications (INDs, CTAs, CTNs, etc.)
    • IMPDs, IBs
    • MAA, NDA / BLA
    • DMF (US) and ASMF (EU)
  • Regulatory Agency Interaction
    • EMA and National Scientific Advice procedures
    • Pre-IND, EOP2 meetings, pre-NDA/BLA meetings
    • EMA SME meetings
    • ITF meetings
    • EMA/HTA parallel consultation
    • PRIME/BTD/RMAT
    • ODD (Orphan Drug Designation)
    • PIP/PSP
  • Regulatory Lifecycle Management
    • Strategy and implementation
    • Post-approval lifecycle management including variations, renewals, PSURs, notifications, etc
  • Other regulatory activities
    • SME status
    • ODD
    • ATMP classification and certification

CMC Regulatory Activities

  • Agency meeting preparation and attendance
  • Revision/writing CMC documents
  • DMF/ASMF revision/writing
  • Responses to Agency Questions
  • Post-approval maintenance
  • CMC Technical Advisory
    • Manufacturing and Quality
    • Analytical Method Development/Validation
    • Potency Assay strategy
    • Release and Stability testing, Specifications
    • Process Development and Validation, QbD
    • Identification of CMO, Technology Transfer and Comparability

Non-clinical and Clinical

  • Strategic development
  • Revision/writing non-clinical and clinical documents
  • Review clinical protocols:
    • FIH, Exploratory and Confirmatory
  • Agency meetings:
    • Preparation and attendance

Draft/review non-clinical and clinical data, defend and review company position

Áreas de interés para futuras colaboraciones

Participar en los consorcios que se formen en el contexto de ayudas/fondos europeos como Horizonte Europa, Programa Misiones, etc.