Regulatory Writing
Regulatory Writing – Clear, Compliant, and FDA-Ready
At ADI Backoffice, we simplify complex regulatory processes by delivering clear, compliant documentation ready for FDA and global submissions. Our expert team excels in crafting precise, well-organized documents that accelerate approval timelines, reduce regulatory obstacles, and facilitate smooth communication with health authorities.
Our Cutting-Edge Regulatory Writing Services
Study-Related Documentation
Accurate and well-structured study documentation is critical for clinical trials and regulatory approvals. We provide:
- Clinical Trial Protocols
- Study Concept Sheets
- Informed Consent Forms (ICF)
- Statistical Analysis Plans (SAP)
- Clinical Study Reports (CSRs)
- Patient Safety Narratives (PSNs)
- Clinical Evaluation Reports (CER)
Clinical Submission Writing
We develop high-quality, submission-ready documents aligned with global regulatory guidelines, including:
- Investigational New Drug Applications (INDA) & Pre-INDA Documentation (Clinical only)
- Common Technical Documents (CTD/eCTD)
- Integrated Summaries of Safety (ISS)
- Integrated Summaries of Effectiveness (ISE)
- 7.3 / 2.7.4 Reports
- Regulatory Submissions & Correspondence
Document-Level Publishing & Compliance
Ensuring regulatory documents are properly formatted, validated, and compliant with submission requirements:
- Document-Level Publishing of CSR
- Validation Check of CSR
- Compliance Support
Safety Reports & Other Regulatory Documents
Comprehensive documentation for safety monitoring, risk management, and regulatory compliance:
- Safety and Risk Management Documents
- Investigator Brochures (IBs)
- Labeling and Package Inserts
- Regulatory Consulting
Why Choose ADI Backoffice?
Precision & Accuracy
Every document is crafted with meticulous attention to detail.
Regulatory Expertise
Compliance with FDA, EMA, and global regulatory standards.
Seamless Approvals
Streamlined processes to accelerate regulatory submissions.
Reliable & Efficient
Meeting tight deadlines without compromising quality.
