Submission Publishing
RegOrbit is your strategic partner to meet your goals in Regulatory Document and Submission Publishing
Technology Support
RegOrbit offers services to manage Regulatory systems and user support
Process Optimization
RegOrbit experts assist to optimize your Regulatory business process
COMPLETE REGULATORY OPERATIONS SERVICES TO MEET OUR CUSTOMER NEEDS
Efficient, Affordable, Full featured and Quality solutions and services for companies of all sizes. Let’s talk about how we can partner with you on the support and services you need.
Delivering future Regulatory Operations Services. Now.
Regulatory information management, publishing, Technology and Document management support and quality services provided on a global scale.
RegOrbit - Global Regulatory Operations Service Company
Exceptional Customer Service
We take pride in providing outstanding services to our customers.
Competitive Prices
We offer high quality Regulatory Operations services at a very competitive price.
Extensive Experience & Track Record
We are experts in Regulatory Operations and one of the most trusted companies with proven industry track records.
Better Service Starts Here
"Outstanding customer service, be meticulous in execution, no matter how big the task and RegOrbit always exceeds our expectations."
HOD – Regulatory Affairs, Indian Generic Pharmaceutical Company
“Thank you Regorbit Team, for your determined and quality of work to make our eCTD New Drug Application without any technical deficiencies.”
Manager Regulatory Affairs, Jordan Based Pharmaceutical company
“Thank you RegOrbit team for preparing and submitting our first ANDA eCTD submission to FDA and it was a pleasure working with you.”
Manager -Regulatory Affairs, A China based Generic Pharma Company
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RegOrbit Services
Our mission is to partner with our clients and strive to provide exemplary service and build strong, lasting relationships.
Regulatory Submission Publishing
- Document Publishing
- Submission Publishing
- Project Management
SOPR/IDMP & eCTD
v4.0
- SOPR/IDMP & eCTD v4.0 Gap analysis
- Product Data Model
- Data Transition Plan
Strategic Consulting & User Training
- Strategic Consulting
- Regulatory Operation Model
- User Trainings
Regulatory Technology Standards
- Technology Solutions
- User Support
- System Validation
XEVMPD Development & Support
- XEVMPD Strategic Consulting
- XEVMPD Business Process
- XEVMPD Service Support
Regulatory Data
Management
- Product Registration
- Data Standards & Governance
- Data Analytics & Reporting
Regulatory Labelling Management
- Structured Product Labeling
- Product Monograph
- Electronic Product Information
Regulatory Business Process Optimization
- Business Process Optimization
- Business Process Map
- Process Automation
News & Events
We look forward to meeting you!
DIA: Regulatory Submissions
DIA: Regulatory Submissions, Information, and Document Management Forum Feb 08, 2021 10:00 AM – Feb 10, 2021 4:15 PM (Eastern Time) Virtual Event
Informa: Global Regulatory Affaris Summit
Global Regulatory Affaris Summit (GPRAS) Take your strategy to the next level with leading advice from Regulatory Authorities, key stakeholders
TOPRA: Digitalisation in Regulatory Affairs
TOPRA: Data Management and Digitalisation in Regulatory Affairs When: 1-3 December 2021 Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United
Australia – ARCS
Australia - ARCS Annual Conference Global impact through innovation and dealing with emerging threats on 4-5 March 2021 at the