Regulatory operations and publishing
VALIRA delivers demonstrated regulatory consulting expertise across the spectrum of global product registration, development, clinical trial consulting and quality management for Drugs, Biologics and Medical Devices.
With Regulatory experience spanning over multiple landscapes like pharmaceuticals, medical devices and biologics, our universal specialists can help you in every step moving from idea to market.
Services we offer Globally:
With Regulatory experience spanning over multiple landscapes like pharmaceuticals, medical devices and biologics, our universal specialists can help you in every step moving from idea to market.
Services we offer Globally:
- Regulatory Filings/Submissions
- Regulatory Consultation and Advice
- Regulatory Strategic Intelligence Services
- Clinical Development
- Global Regulatory Strategy Development
- Ministries of Health Advisory panel preparation and meeting support
- International Regulations and Submissions
- Audit preparation
- Technical files creation support
- Regulatory file letters
- Device classification and predicate device assistance
- Product modification strategies and management
- Pre/Post –Approval regulatory services
- Regulatory Document Management and Publishing
- Regulatory Software Support Services