Turn every submissioninto a registration.
Dossierly maps every document requirement for your product, authority, and submission type, then tracks what you have, what is missing, and what is inconsistent. Know where you stand before you submit.
Pre-submission Checklist
You already know where dossiers fail.
Conditional requirements are not obvious
Your product profile determines which documents are required. The mandatory list is visible. The conditional list is not.
Documents diverge after the dossier is filed
Specifications get revised. Stability protocols get updated. The submitted dossier does not reflect any of it until an evaluator finds the discrepancy.
Inconsistencies survive internal review
A dissolution limit in the specification does not match the value in the stability protocol. Both passed review. Neither flagged the difference.
Query responses start from reconstruction
A query references data submitted months earlier. Finding the source, interpreting the question, and assembling the response takes days it should not.
Four capabilities. One regulatory workflow.
Know exactly what your product needs before you start compiling
Select your product type, target authority, and submission type. Dossierly resolves every document requirement for that specific combination, mandatory and conditional, mapped to CTD section codes. When the guidelines update, the requirements update.
Requirement Mapping
Catch errors with automated cross-document review
Upload your specification and your Certificate of Analysis. Dossierly reads both documents and compares the data points. If the dissolution limit does not match, if a test is absent from the CoA, if the method reference differs, it shows you exactly what is wrong and where.
Cross-Document Review
Specification v3.1
Protocol v2.0
Acceptance criteria conflict
Spec: Q≥80% at 30 min. Protocol: Q≥75% at 45 min. Must align before submission.
Every dossier, every stage, every query in one place
Track each project through the full lifecycle: submission, screening, technical evaluation, query receipt, response, and certificate. When a query arrives, the original submission is on record. Deadlines are visible. Nothing is buried in an email thread.
Submission Tracker
Amoxicillin 500mg Capsules
New Registration · Human Medicine
Submitted
Screening
Under Evaluation
Query Raised
Certificate
Query received, 28 days to respond
3.2.P.8: Provide additional stability data supporting the 24-month shelf life under Zone IVb conditions.
Three steps from product to submission
Register your product
Add product details, link the manufacturer and MAH, set BCS class and route. Two minutes of data entry.
Create a submission project
Pick the regulatory authority and submission type. Document requirements generate instantly, mapped to the correct modules and section codes.
Upload, check, and track progress
Attach documents section by section. The gap analysis updates as you upload. Track the project through every regulatory stage.
Made for teams who live inside dossiers
Local Technical Representatives
You manage dossiers across multiple clients. Each has its own deadlines, product portfolio, and authority relationships. You need to know which project is missing an updated GMP certificate and which query response is due in ten days, without switching between files.
- ✓One dashboard across all active projects
- ✓Gap analysis completed before you compile
- ✓Query tracking with deadlines and document records attached
Pharmaceutical manufacturers with in-house RA teams
Your portfolio is growing. Each new market adds a new set of authority-specific requirements. Your RA team is experienced, but the volume of dossiers at different regulatory stages is stretching what is manageable with manual tracking.
- ✓Requirement mapping that adjusts when you add a dosage form or market
- ✓Cross-document review that catches what internal review misses
- ✓Submission records that make query responses faster to assemble
Pricing built around how RA teams actually work
We are finalising pricing that reflects the realities of regulatory work in Kenya, not generic SaaS seat fees. Early access partners set the benchmark. If you are an LTR, MAH, or RA consultancy, reach out before we publish numbers.
No per-seat monthly fees. We are exploring submission-based and project-based models suited to Kenyan RA practice. Early access partners help shape final pricing.