Pharma Regulatory Consulting Services
Pharma Regulatory Consulting Services
RABT is a trusted provider of Regulatory Affairs Services to the global life sciences industry, specializing in regulatory affairs operations and strategy consulting. Our mission is to help our clients reduce costs and time to market by providing flexible, information-based services. Our global Regulatory Affairs and Consulting Services offer up-to-date regulatory expertise across all types of products to support product lifecycle management and submission strategies.
We understand that each client has unique needs, which is why our blended onshore and offshore model can be tailored to meet those specific requirements. Regulatory Affairs and Consulting Services offer clear visibility and control over diverse product portfolios, increased operational efficiencies, reduced costs, and ongoing regulatory compliance.
Pharma Regulatory Consulting Services expertise
Clinical and non-clinical services
- Toxicological risk assessment,
- Aggregate report services,
- ICSR services,
- literature monitoring services,
- periodic benefit-risk evaluation report,
- Periodic adverse drug experience.
Label and artwork services
- Graphic designing and proofreading services,
- Content to carton and printing services,
- global labeling
- Regional labeling for the US, Europe, and ROW.
eCTD publishing services
- global publishing and submission services,
- NeeS submissions,
- legacy conversions,
- CSR report level publishing,
- Structured product labeling,
- Regulated product submissions.
LCM services
- ANDA, NDS, MAA, NDA, and
- New product authorizations for finished products and APIs.
Partnering with RABT ensures you have access to experts in Regulatory Affairs and Consulting Services, delivering high-quality solutions that allow you to streamline your operations and improve your bottom line.
