Submissions
Our team consists of highly experienced Regulatory Operations professionals with extensive experience specializing in Health Canada and FDA submissions.
eCTD Services for Streamlined Regulatory Submissions
With our eCTD expertise, we help you navigate the complex regulatory environment efficiently, ensuring compliance and accelerating the submission process.
At Texium Solutions, we provide comprehensive eCTD services, including:
Advice & Creation
Guidance on the creation, conversion, and response processes for INDs, NDAs, ANDAs, DMFs, NDS, ANDS, and more.
Electronic Submissions
Handling electronic submissions via gateways and on media to agencies or clients, as required.
eCTD Identifier Management
Requesting eCTD identifier numbers from regulatory agencies.
Regulatory Enrollment Process
Managing the entire REP, ensuring smooth enrollment and submission processes.
NeeS Services for Efficient Regulatory Submissions
Our NeeS expertise ensures your submissions are compliant and timely, streamlining the process for regulatory success.
At Texium Solutions, we offer comprehensive NeeS services, including:
Advice & Creation
Guidance on the creation, conversion, and response processes for CTAs, DINs, and medical device license applications.
Electronic Submissions
Handling electronic submissions on media to agencies and/or clients as required.
Regulatory Enrollment Process
Managing the entire REP, ensuring efficient regulatory enrollment and submission management.
SPL and XML PM Services for Regulatory Compliance
At Texium Solutions, we provide comprehensive services for SPL and XML PM, including:
- Create SPL and XML PM Documents – Develop and manage regulatory submissions for drug establishment registrations, no changes notifications, and drug/product listings.
- Create NDC Labeller Requests – Generate NDC labeller request SPLs to meet regulatory requirements.
- GDUFA Self-Identification – Prepare and submit GDUFA self-identification SPLs for compliance.
- Convert Canadian PMs – Convert Canadian PMs into XML PM formats for seamless integration.
- Electronic Submissions – Efficiently electronically submit SPLs and XML PMs to regulatory agencies and stakeholders.
Our SPL and XML PM expertise ensures accurate, compliant, and timely submissions for your regulatory needs
Why Choose Texium Solutions?
Proven Expertise
Decades of experience in research informatics and regulatory compliance.
End-to-End Support
From consultation to implementation, we offer comprehensive solutions.
Scalability & Security
Future-proof solutions designed for high-performance research environments.
Seamless Integration
Compatible with leading industry platforms for a unified digital experience.
Optimize Regulatory Research with AskFDA’s Smart Framework
Let’s connect and take your compliance strategy to the next level!
