REVIO PHARMACEUTICAL CONSULTANTS
WORKING TOGETHER FOR
INNOVATION IN MEDICINES
REVIO is a Regulatory Affairs Consultancy
REVIO is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs) and biologics for human use, across all phases of the development, from non-clinical to post-marketing, to comply with regulatory requirements.
WE HAVE REAL EXPERTISE IN ADVANCED THERAPY
MEDICINAL PRODUCTS (ATMPS) AND BIOLOGICS
We work together with our clients to address key strategic regulatory challenges. Our scientific expertise covers manufacturing, non-clinical and clinical. With our support, you can cut the time and associated cost it takes to get your products to market.
Our experts are continuously involved in regulatory processes with Regulatory Agencies in Europe (i.e. EMA, National Competent Authorities), US, Canada, etc.
The advice you get from REVIO is from REAL experts in the industry and former regulators who have been involved in shaping today’s regulatory environment.
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.