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Regulatory Publishing and Submissions
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Regulatory Publishing and Submissions ā Overview
From initial dossier development to final HA submission and acknowledgment, Pharma Wizard supports every stage of the publishing process. Our 260+ global submission experts deliver high-quality, on-time submissions across North America (USA and Canada), Europe, LATAM, MEA, and RoW.
- eCTD, NeeS, and paper submissions
- Region-specific formatting and compliance
- Submission planning, tracking, publishing, and confirmation
- End-to-end submission lifecycle management
In addition to expert-led services, Pharma Wizard offers .Submit, our proprietary eCTD publishing and electronic submission software. This advanced tool ensures compliance with ever-evolving HA requirements and accelerates product approvals for drugs, biologics, and medical devices.
With Pharma Wizard, Regulatory Publishing and Submissions become a strategic advantageāreducing delays, increasing efficiency, and ensuring global Regulatory compliance.
Pharma Wizardās Regulatory Publishing and Submissions
Al-powered Regulatory
Next-gen Regulatory solutions empowered by Al
eCTD Publishing and Submission Services
Efficient eCTD services for HA requirements for marketing approval /dossier filings
NeeS Submissions
An alternate electronic format that are neither required nor accepted in eCTD format
Paper Submissions
Streamlined Paper submissions to the global and local HA standards (volumes, binders, TOC, hard copy, DVD)
CSR - Report-Level Publishing
Precision publishing services for CSR, ensuring compliance with ICH E3 and electronic submission requirements
Legacy Conversions
Seamless transition solutions for legacy data
AD promo submission services
Accurate submission of promotional material to HA
Archiving Services for Regulatory Publishing and Submission
Secure, expert-driven archiving for streamlined regulatory submissions
Data Migration Services
Accurate and Compliant Data Migration Solutions
Document Formatting
Tailored templates ensuring seamless regulatory compliance
Submission QC Automation
Enhancing submission accuracy with advanced automation
Auto Document Level Publishing
Automate your regulatory publishing for error-free, compliant submissions
Regulatory Affairs Services
- Expertise
- Advantages
- Comprehensive Regulatory expertise offering a seamless submission support experience, backed by our dedicated team consisting of a Publishing Manager, Lead Publisher, Senior Publishing Specialist, and Document Specialist
- Experienced global publishing network ensuring submissions with quick turnaround times
- Responsive to last-minute submission requests and ad hoc support
- Tailored service models, including dedicated team support for specific project requirements
- Onshore/offshore resource flexibility to optimize cost and efficiency
- Expert project management and technical oversight for seamless operations
- Hassle-free system migration support
- Clearly defined and repeatable submission processes
- End-to-end submission tracking and management
- Strategic submission planning for major reports and applications
- Full compliance with Health Authority standards
- Rigorous quality checks and review processes at every stage
- Secure and timely dispatch services to global Health Authorities
- Reliable archiving solutions to ensure traceability and future compliance
- Full-spectrum application management: NDA, BLA, IND, DMF, NDS, ANDS, MAA, CTA, and lifecycle maintenance submissions
- Expertise in diverse submission types: Amendments, Variations, Safety Reports, Annual Reports, and Advertising/Promotional Submissions
- Advanced eCTD 4.0 capabilities: Ensuring seamless compliance with the latest Regulatory requirements
