Comprehensive Regulatory Solutions
Our regulatory affairs team provides strategic guidance and hands-on support throughout the product lifecycle. From early development through post-market requirements, we ensure your regulatory pathway is optimized for success across global markets.
Regulatory Operations
- Document management and publishing
- Submission tracking and management
- Agency correspondence management
- eCTD compilation and submission
Regulatory Strategy
- Global regulatory strategy development
- Regulatory gap analysis and remediation
- Regulatory intelligence and assessment
- Agency meeting preparation and support
Comprehensive Coverage Across Development
CMC Strategy
- • Drug substance development
- • Drug product development
- • Analytical methods
- • Stability programs
- • Manufacturing controls
Medical Devices
- • 510(k) submissions
- • PMA applications
- • De Novo requests
- • CE marking strategy
- • Quality system compliance
Pre-clinical Development
- • IND-enabling studies
- • Toxicology strategy
- • IMPD preparation
- • Pharmacology packages
- • Safety assessments
Clinical Development
- • Protocol development
- • Clinical study reports
- • Safety reporting
- • DSUR/PSUR preparation
- • Investigator brochures
Global Submission Expertise
We provide comprehensive support for regulatory submissions across major global markets, ensuring your applications meet the specific requirements of each regulatory authority.
US FDA Submissions
- • IND Applications
- • NDA/BLA Submissions
- • 505(b)(2) Applications
- • ANDA Submissions
- • Orphan Drug Designations
- • Fast Track/Breakthrough Therapy
EU EMA Submissions
- • CTA Applications
- • MAA Submissions
- • Centralized Procedures
- • Decentralized Procedures
- • Mutual Recognition
- • Scientific Advice
GL Global Markets
- • Health Canada Submissions
- • PMDA (Japan) Applications
- • TGA (Australia) Dossiers
- • Swissmedic Applications
- • MHRA (UK) Submissions
- • Emerging Markets Strategy
Expert Regulatory Authoring
Our experienced medical writers and regulatory professionals create high-quality documentation that meets regulatory standards and accelerates approval timelines.
Clinical Documents
- ✓ Clinical Study Protocols
- ✓ Clinical Study Reports
- ✓ Patient Narratives
- ✓ Clinical Summaries
- ✓ Benefit-Risk Assessments
Regulatory Documents
- ✓ Module 2 Summaries
- ✓ Briefing Documents
- ✓ Response to Questions
- ✓ Labeling Documents
- ✓ Risk Management Plans
Why Choose Kalvion Sciences for Regulatory Affairs
Proven Track Record
Successfully supported 200+ regulatory submissions with high approval rates across multiple therapeutic areas
Global Expertise
Deep understanding of regulatory requirements across FDA, EMA, and 40+ other regulatory authorities worldwide
Accelerated Timelines
Efficient processes and experienced teams that consistently deliver high-quality submissions ahead of schedule
Navigate Your Regulatory Pathway with Confidence
Partner with our regulatory experts to ensure successful submissions and faster market access for your products.
Start Your Regulatory Journey