About Us
Developing strategies, implementing tactics, and brainstorming innovative ways to obtain approval of our sponsors’ products.
Rio Pharmaceutical Services, LLC (RPS) is a consulting company specializing in highly strategic drug-development advice and services for our partners in the pharmaceutical and healthcare industry.
RPS accesses a network of 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.
The highly experienced RPS team successfully navigates across therapeutic areas, interacting with FDA divisions while building global development programs.
RPS has cultivated a favorable reputation for collaborating with clients to provide embedded or virtual solutions. We do this by integrating seamlessly into product teams and by advising senior management.
RPS also provides medical writing and submission services:
• Medical and scientific writing experts compose a broad range of clinical and non-clinical documents and publications needed throughout a product’s development and for global regulatory submissions.
In addition, RPS operations and submissions experts have an approved FDA gateway and use validated eCTD software to perform client IND, IDE, NDA, BLA, PMA 510ks, and pharmacovigilance to the FDA.
Areas of Expertise
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
- ESafety data analysis – drugs, devices and biologics
- Regulatory intelligence, including data assessment for “what-if” scenarios
- Clinical development planning and trial design
- Nonclinical / toxicology regulatory development
- Pharmacokinetics / pharmacodynamics
- U.S. agent to FDA
- Over-the-counter medicines (OTC)
- Extensive Dermatology experience
- Biologics, vaccines, & devices
- Expert witness experience
Contact Us