Overview
Regulatory submissions are expensive, and any misstep can lead to significant costs, delays, and increased anxiety among management, board members, and investors. You’re at the finish line —let us partner with you to cross it successfully. With tailored solutions and services, we provide cost-effective expertise to ensure your submission is compliant, efficient, and successful. At Submify, we simplify the complex, giving you confidence and clarity as you take your product to market.
Unmatched Expertise
Backed by years of submission experience and a proven track record, the Submify team is ready to support you on your next submission with confidence and expertise. We deeply understand regulatory submission requirements and CDISC data standards to ensure compliance and success.
Cutting-Edge Technology
Advanced automation and compliance tools streamline processes, reduce errors, and increase submission success rates.
Tailored Solutions
Our tools and services are customized to meet the unique requirements of your study and regulatory goals.
Global Reach
With expertise in FDA, EMA, PMDA, and other regulatory bodies, we ensure compliance across multiple regulatory agencies.
Commitment to Quality
Rigorous quality control ensures submissions meet the highest standards of accuracy and integrity.
Our Services
Regulatory Submission Expertise
-
Seamless guidance for IND, NDA, and BLA submissions with the FDA.
-
Global support for submissions to EMA, PMDA, and other regulatory bodies.
-
Ensuring timely, compliant, and audit-ready submissions.
CDISC-Compliant Data Solutions
-
CDASH and SDTM-compliant Case Report Forms.
-
Gap Analysis of study documents and datasets for compliance.
-
Development of ADaM datasets, Reviewer’s Guides, and Define.xml files.
-
Integration of controlled terminology and automated generation of annotated CRFs.
BIMO (Bioresearch Monitoring)
-
Automated creation of clinsite BIMO datasets and site-level subject data listings.
-
Inspection readiness support for audits by FDA, EMA, and other agencies.
ISS/ISE Report Development
-
Preparation of Integrated Summary of Safety (ISS) and Efficacy (ISE) reports.
-
Regulatory-compliant data integration for submission excellence.
Submify Solutions
CDISC Compliance Made Easy
-
Automated compliance checks using the CDISC Open Rules Engine (CORE) and custom rules for SDTM and ADaM datasets.
-
Early gap identification ensures adherence to standards and reduces review cycles.
Submission Package Preparation
-
Utility-driven generation of XPT files, Define.xml, and Reviewer’s Guides (cSDRG, ADRG, BDRG).
-
Automated development of clinsite BIMO datasets and site-level, subject data listings.
-
Simplified creation of aCRFs, including bookmarking for clarity.
Streamlined eCTD Support
-
Automated structure validation and checks for naming conventions and file types.
-
eCTD components are organized and audit-ready for seamless submissions.
Centralized Submission Review Platform
-
A comprehensive platform for reviewing datasets, collating clinical study reports (CSRs), appendices, common technical documents (CTDs), and FDA briefing materials.
-
Facilitates team collaboration and streamlines submission review processes.
Partner with Submify
Ready to take the stress out of submissions? Partner with Submify for expert guidance, cutting-edge tools, and guaranteed compliance. Contact us today to make your next submission a success!
