RegIntel
"Your complete dossier — in weeks, not months."
Reads your clinical study reports and product data, identifies gaps for CDSCO, FDA, or EMA, and compiles the complete regulatory dossier in the correct format. Your team reviews and submits — not rebuilds.
CDSCO / FDA / EMA
Gap analysis
eCTD formatting
Dossier compilation
ComplianceGuard AI
"No regulatory surprise reaches your team unannounced."
Reads new regulatory guidance from CDSCO, WHO, FDA, and EMA continuously — assesses impact on your products — and tells your team exactly what needs to change. Always ahead, never catching up.
Real-time monitoring
Impact assessment
Change management
Multi-authority
SubmitIQ
"Submission-ready. Every time."
Plans, authors, and manages regulatory submissions across multiple health authorities simultaneously — tracking status, managing response timelines, ensuring nothing falls through across your global regulatory programme.
Multi-authority planning
Timeline management
Status tracking
Response management
BatchIQ
"Batch release decisions made with confidence."
Reviews batch manufacturing records, QC test results, and deviation reports against your approved specifications. Generates a complete release decision summary so your QP can approve with full confidence and a complete evidence trail.
Batch record review
QC result analysis
Deviation assessment
GMP compliant
CMCReview AI
"Your CMC package reviewed for quality and compliance."
Processes your Chemistry, Manufacturing and Controls documentation — formulation data, manufacturing process descriptions, stability study reports, analytical method validations — and identifies every gap against FDA and EMA CMC requirements.
CMC gap analysis
Stability validation
Impurity assessment
ICH Q1A compliance
LabelGuard
"Every label difference found before FDA finds it."
Reads your proposed generic drug label and the Reference Listed Drug label side by side — performing a precise, section-by-section comparison that identifies every difference in Boxed Warnings, Indications, Dosage, and Contraindications.
Label comparison
21 CFR annotation
Deviation classification
Annotation report
MedWrite AI
"First-draft CTD summaries in hours, not weeks."
Reads your clinical study reports, nonclinical data packages, and existing product quality documents and generates complete Module 2 CTD summaries formatted to FDA and EMA eCTD v4.0 specifications — with full source document traceability.
Module 2 CTD authoring
eCTD v4.0 output
Source traceability
Section refinement
QueryIQ
"FDA asks. QueryIQ finds the answer and drafts the response."
When FDA issues an Information Request or EMA issues a List of Questions, QueryIQ searches your entire submission package, clinical study databases, and prior regulatory correspondence to draft a complete, cited response.
Cross-submission retrieval
Response drafting
Citation linking
Deadline management