FDA SEND Compliance: Why Expert Consulting is Vital for Nonclinical Regulatory Success

In today’s highly regulated drug development environment, accurate and compliant nonclinical data is essential for regulatory approval. As CDISC SEND (Standard for Exchange of Nonclinical Data) becomes a global regulatory requirement—particularly with the FDA—sponsors must ensure that their data submissions meet evolving technical standards. However, aligning your data with SEND compliance expectations can be complex without expert guidance. 

That is where BioBoston Consulting comes in. Our experienced team provides tailored FDA SEND consulting services, offering strategic support in SEND dataset conversion, validation, and regulatory submission planning. In this article, we break down the value of SEND consulting and how BioBoston Consulting can streamline your submission journey. 

 

What is SEND and Why It Matters for FDA Submissions? 

SEND is a standardized format created by CDISC for submitting nonclinical study data to regulatory agencies such as the FDA. It is designed to: 

• Promote consistent data structure and terminology 

• Enable machine-readability and traceability 

• Facilitate faster, more efficient regulatory reviews 

Since 2016, the FDA has required SEND format for most IND, NDA, and BLA submissions involving toxicology or pharmacology studies. SEND is now a critical regulatory component—much like eCTD for clinical and CMC data. 

 

FDA Requirements and Common SEND Pitfalls 

SEND compliance is governed by the FDA’s Data Standards Catalog, which defines acceptable SENDIG versions, applicable study types, and mandatory controlled terminologies. Submitting non-SEND or outdated formats can trigger Technical Rejection Criteria (TRC) flags, halting your submission. 

Common challenges include: 

• Use of invalid SEND versions 

• Missing or improperly structured datasets 

• Inconsistent metadata and terminology 

• Errors in Define.xml or SDRG files 

• Poor legacy data mapping 

BioBoston Consulting helps you avoid these costly mistakes with proactive, expert-driven solutions tailored to your study and submission timeline. 

 

The Strategic Role of FDA SEND Consultants 

SEND is not just about formatting data—it is about ensuring regulatory readiness. SEND consultants at BioBoston Consulting support every phase of the submission process: 

Early Engagement and Study Design Support 

We help integrate SEND planning at the protocol development stage by: 

• Designing SEND-compliant data collection forms 

• Aligning with CROs and data vendors 

• Defining metadata and controlled terminology early 

This proactive approach reduces costly rework during submission. 

Legacy and Hybrid Data Management 

Many companies face the challenge of converting legacy nonclinical studies to SEND. Our consultants: 

• Conduct SEND readiness and gap analyses 

• Create hybrid SEND mappings when data is incomplete 

• Develop documentation for missing variables in the SDRG 

We ensure that critical historical data can still support current regulatory submissions. 

Data Mapping, Validation, and Submission Packaging 

Our SEND specialist’s handle: 

• Accurate mapping from raw to SEND domains 

• Creation of compliant .xpt datasets 

• Generation of Define.xml and Study Data Reviewer’s Guide (SDRG) 

• Comprehensive dataset validation using Pinnacle 21 and other FDA-compliant tools 

 

CDISC SEND Services We Offer 

BioBoston Consulting’s CDISC SEND services are designed for full-spectrum support, including: 

• SEND readiness assessments 

• Controlled terminology alignment 

• Dataset creation and QA 

• SDRG and Define.xml development 

• Validation and compliance reporting 

• Integration into eCTD (Module 4) 

We ensure traceability, consistency, and regulatory confidence—key pillars for successful FDA and global submissions. 

 

Aligning SEND with New Labelling and Regulatory Frameworks 

Recent updates to labeling and safety regulations require structured, traceable nonclinical data to support: 

• Safety claims and adverse event tracking 

• Evidence-based risk assessments 

• Precautionary labeling and contraindications 

Our SEND consultants align datasets (e.g., LB, CL, RE domains) with your product’s safety narrative, ensuring your submission stands up to both scientific and regulatory scrutiny. 

 

Why BioBoston Consulting is Your Trusted SEND Partner 

As a trusted name in regulatory data services, BioBoston Consulting provides strategic value by offering: 

✅ Faster submissions with fewer validation errors
✅ Cost-efficient scalability for single or multiple studies
✅ Improved FDA interactions with clean, compliant data
✅ Integrated SEND services that align with your broader regulatory strategy 

Whether you are planning a first-in-human study or submitting an NDA, our team helps you navigate SEND conversion and compliance with precision and confidence. 

 

Ready to Streamline Your SEND Submissions? 

Avoid costly delays, rejections, and compliance issues. Partner with BioBoston Consulting for comprehensive FDA SEND consulting and CDISC SEND services that ensure your nonclinical data is accurate, standardized, and submission ready. 

📞 Contact us today to schedule a SEND readiness assessment or get support on your next submission. 

👉 Reach out now and let BioBoston Consulting be your partner in regulatory success.