REVIO PHARMACEUTICAL CONSULTANTS
Contact information
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
Areas of activities
- Biodrugs
- Biomarkers
- Stem cells
- Cell cultures
- Drug development
- Screening
- Cellular Therapy
- Gene Therapy
- Biomaterials and tissue therapy
- Transplant
- Consultancy
- Maintenance of cell cultures
MISSION
Our mission and passion are to work for our clients and to combine the strength of our expertise and innovation to advance their success in preventing and curing disease.
VISION
REVIO PHARMACEUTICAL CONSULTANTS strives to be the premier provider of regulatory advice to biopharmaceutical companies for the development and registration of innovative medicines as ATMPs.
OUR VALUES
- INTEGRITY.
- QUALITY.
- COMMITMENT.
- FLEXIBILITY.
- PASSION.
Products and services
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
Areas of interest for future collaborations
Participate in consortia that are formed in the context of European grants / funds such as Horizon Europe, Missions Program, etc.