Dossier Compilation &
Regulatory Support
At Rubicon Research, our regulatory team has a sound understanding of global regulatory requirements. Our in-house team of regulatory experts facilitates meeting challenging timelines and our processes are designed to provide cost effective study management solutions towards regulatory authorizations.
We provide the following regulatory services:
- Strategies to obtain effective and efficient pathway towards required regulatory approvals
- Submit dossiers to US FDA and EU authorities for approvals
- Address deficiency questions and generation of data during registration phase
Quick Links:
Corporate HQ and R&D Center
Rubicon Research Private Limited
MedOne House, Plot No. B-75,
Road No. 33, Wagle Estate,
Thane (W) 400604,
Maharashtra, India
Contact: +91 22 61414000
Manufacturing Plant
Rubicon Research Private Limited
Plot no. K 30/4 & 30/5,
Additional MIDC, Ambernath,
District Thane 421 506,
Maharashtra, India
Contact: +91 251 2628100
USA Office
Rubicon Research Private Limited
Suite 605, Princeton Office Center II,
666 Plainsboro Road, Plainsboro,
New Jersey 08536
United States of America
Canada R&D Center
Rubicon Research Canada Limited
255 Spinnaker Way,
Unit 6, Concord,
Ontario, L4K 4J1,
Canada
Consumer Healthcare
Rubicon Consumer Healthcare Private Limited
MedOne House, Plot No. B-75,
Road No. 33, Wagle Estate,
Thane (W) 400604,
Maharashtra, India
Contact: +91 22 61414000
Learning Solutions
Rubicon Academy LLP
MedOne House, Plot No. B-75,
Road No. 33, Wagle Estate,
Thane (W) 400604,
Maharashtra, India
Contact: +91 22 61414000