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.
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.
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.
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:
- 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.
Our Team of Experts provides you with:
- 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.
- 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.
- 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.
- 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.
- IMPD, CTA and IND.
- MAA, BLA, CTD, Hospital exemption.
- DMF (US) and ASMF (EU).
- eSubmission: eCTD.
- eSubmission: Best Practices.
- eSubmission: PDF Publishing.
- eSubmission: Expertise.
- eSubmission: Gateways.
- eSubmission: MS Word Publishing.
- Portfolio maintenance in EU: Variations, Renewals, PSURs, Notifications.
- Communications with Health Authorities and Submissions.
- Long-term project management.
- Due diligence: inlicence and outlicence.