- 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

Rio Pharmaceutical Services, LLC

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