Regulatory Affairs
consulting solutions
In the ever-changing pharmaceutical regulatory environment, it is important for pharmaceutical companies to keep abreast of the knowledge in international legislations, guidelines and customer best practices globally and locally
Regulatory affairs
consulting
& strategies
Our Regulatory Affairs Services at a Glance
- Advice on Regulatory strategies for successful product market entries across the globe
- Guidance for regulatory pathway that is necessary for timely regulatory approval
- Advice on industry trends and current market needs
- Advice on Regulatory Affairs and Regulatory Operations Outsourcing
- Advice on the Regulatory mergers and acquisitions
- Regulatory classification of products across different jurisdictions
- Conduct face-to-face Meetings with Regulatory Authorities
- Provide expert regulatory CMC compliance advice throughout development
Regulatory Affairs Services
Predefined support
- FDA registration and labeler code
- US FDA Agent Service
- FDA Registration Renewal
- FDA Food Facility Registration
Ongoing support
- eCTD Publishing and Validation
- Dossier development and submission
- Premarket Notification(510k)
- Medical Device Establishment Registration & Listing with US FDA
- Structured Product Labeling for Establishment and Product
Adhoc Support
- Registration of Food facilities
- Dietary supplement –
Review the product Labeling - Food Supplement – Prior Notice
- Voluntary Cosmetic Registration Program
- Cosmetic Labeling Review
- FDA Unique Device Identifier
