- 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
Company Details
- Employees
- 8
- Founded
- -
- Address
- 135 Walter's Brook Drive, Bridgewater,nj 08807-5633,united States
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://www.riopharma.com/
- HQ
- Bridgewater, NJ
Rio Pharmaceutical Services, Llc Questions
Rio Pharmaceutical Services, Llc's website is http://www.riopharma.com/
Rio Pharmaceutical Services, Llc's LinkedIn profile is https://www.linkedin.com/company/rio-pharmaceutical-services-llc
Rio Pharmaceutical Services, Llc has
8 employees.
View email and phone details for 8
employees at Rio Pharmaceutical Services, Llc.
Rio Pharmaceutical Services, Llc's industry is
Pharmaceutical Manufacturing
Rio Pharmaceutical Services, Llc's top competitors are
Farmalab,
Hemofarm A.d.,
Rio Pharmaceuticals, Inc.,
Galenika,
Intavis Peptide Services,
Hospinova Sprl,
Bird Medical,
Five Med,
Quíronmed - Equipamentos Médicos Hospitalares,
Bird Meditech.
Rio Pharmaceutical Services, Llc's categories are Pharmaceutical Manufacturing
Rio Pharmaceutical Services, Llc's founding year is 2000
