REVIO PHARMACEUTICAL CONSULTANTS
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.