Rio Pharmaceutical Services, LLC

- Consulting company specializing in highly strategic drug-development advice and services for our partners in the pharmaceutical and healthcare industry - Recognized insightful leaders who seek and create opportunities throughout the product life cycle to ensure each client’s asset is successfully transformed into a valuable therapy for patients - Experienced team that successfully navigates across therapeutic areas, interacting with FDA divisions and building global development programs - Collaborates with clients to provide embedded or virtual solutions by integrating seamlessly into product teams and advising senior management - Also provides medical writing and submission services: Medical and scientific writing experts author a broad range of clinical and non-clinical documents and publications needed throughout a product’s development and for global regulatory submissions - Operations and submissions experts have an approved FDA gateway and use validated eCTD software to perform client IND, NDA/BLA and pharmacovigilance to the FDA. For a vast array of therapeutic categories, we provide: - Strategic pharmaceutical analysis and brainstorming, including clinical and regulatory development - Regulatory evaluations – expert data analysis, review and reporting - Regulatory and medical due-diligence reviews, including evaluating data for licensing candidates - Safety data analysis – drugs, devices and biologics - Regulatory intelligence, including data assessment for “what-if” scenarios - Clinical development planning and trial design. Services Provided: - Briefing packages: from pre-IND to pre-NDA (drugs) from pre-IDE to pre-PMA or 510k (devices) - INTERACT Program, pre-BLA (biologics) - IND preparation - Preparation of regulatory applications in eCTD standard, including NDAs, 510ks, PMAs & BLAs - Strategic documents for internal decision-making, including white papers - New-product and marketing-materials evaluations -Report writing for all clinical-trial phases