20 years of experience in Regulatory Affairs
We have collaborated with Biopharmaceutical Companies and Public institutions in the field of ATMPs working among others with Oncolytic viruses, Adeno-associated virus (AAV), Plasmids, Adenovirus (AdV), CAR-T, Mesenchymal stem cells, Bone marrow-derived hematopoietic stem cells, Adipose-derived stem cells, etc.
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Revio Offers
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REVIO provides you with hands-on, flexible resources and expanded operational capability, to implement a compliant drug development strategy and timelines.
Full regulatory service in Quality/CMC, non-clinical and clinical consulting resources to biopharmaceutical companies for the development and registration of innovative medicines as ATMPs.
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Our Quality/CMC, non-clinical and clinical regulatory consultants combine in-depth technical knowledge of product development with risk-based submission content and regulatory strategies for all phases of the review and approval process. This breadth of pharmaceutical development expertise provides you with a single, integrated source for efficient problem-solving strategies and scientific expertise. Whether your needs are comprehensive or tightly focused on a specific project, our experienced consultants will help to keep your drug development program on track.
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Regulatory affairs expertise to ensure that your development program delivers the data and information required to meet reviewer expectations for each stage of development, registration and post-authorization.
Knowing the main scientific/regulatory
challenges for ATMPs developers:
- Characterization.
- Potency testing (related to clinical outcome)
- Availability of relevant animal models.
- Proof of concept, safety aspects (species specificities).
- Possibilities for blinding, availability of comparators.
- Feasibility of dose finding and biodistribution studies in humans, concomitant medication/surgical procedures, efficacy.
- Safety: dose, tumourigenicity, biodistribution, integration.
- Efficacy: inter-individual variability, administration.
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Our Team of Experts provides you with:
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REGULATORY ROADMAPS
- Strategic regulatory and scientific assessment by providing CMC, non-clinical and clinical development plans, to bring your product to the patient in the most efficient way.
- Feasibility assessment, including overview of development timelines and costs.
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SCIENTIFIC ADVICE
- CMC, preclinical and clinical.
- Expertise for optimal outcome with AEMPS, EMA, EU-NCAs, FDA, Canada, etc.
- Preparation of briefing packages and attendance to the meetings with authorities.
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CLINICAL TRIALS
- Preparation of Investigational Medicinal Product Dossier (IMPD).
- Preparation of Investigator’s Brochure (IB).
- Clinical Trial Application (CTA) submission in EU.
- Preparation of Investigational New Drug (IND) application.
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REGULATORY TOOLS
- ATMP: Classification and certification.
- PRIority MEdicines (PRIME) and accelerated assessment.
- Preparation and Management of Orphan Drug Designation (ODD) procedure including presubmission advice (EMA and FDA)
- Paediatric Investigation Plan (PIP) and Pediatric Study Plans (PSPs).
- Classification of your company as SME (Small Medium Enterprise).
- US Expedited Programs: RMAT, Breakthrough Therapy, etc.
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DOSSIER WRITING
- IMPD, CTA and IND.
- MAA, BLA, CTD, Hospital exemption.
- DMF (US) and ASMF (EU).
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PUBLISHING
- eSubmission: eCTD.
- eSubmission: Best Practices.
- eSubmission: PDF Publishing.
- eSubmission: Expertise.
- eSubmission: Gateways.
- eSubmission: MS Word Publishing.
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OTHERS
- Portfolio maintenance in EU: Variations, Renewals, PSURs, Notifications.
- Communications with Health Authorities and Submissions.
- Long-term project management.
- Due diligence: inlicence and outlicence.