Ever wondered what happens to your product file after you finally submit it? It doesn’t go straight to approval — instead, it embarks on a multi-step journey through regulatory desks, technical reviews, and hidden bottlenecks. This is the real story of your dossier in motion — and why many approvals stall before they even start.
Step 1: The Desk Review
The journey begins with a regulatory assistant, who checks the submission for formatting, completeness, and required documents.
Common pitfalls:
- Missing forms
- Mismatched module labels
- Unsigned declarations
Even minor oversights can trigger immediate rejection — before a single technical review is done.
Step 2: Technical Review by Specialists
If it passes the desk, the dossier moves to subject-matter experts for deeper technical assessment. This includes API data, formulation consistency, stability studies, and label compliance.
What’s often overlooked?
Generic, copy-pasted dossiers.
Especially in countries like Nepal, dossiers must reflect local nuances — or face immediate rejection.
Step 3: The Query Queue
Your file might pause here. Why?
Because errors or inconsistencies throw it into a deficiency cycle.
Common delays include:
- Mismatched manufacturer names
- Missing legalizations
- Inadequate shelf-life justification
Step 4: Regulatory Committee Review
In markets like Uganda, where the NDA committee meets just once a month, even a tiny mistake can mean waiting until the next review cycle.
One slip = One month lost.
And every delay adds cost and uncertainty to your export timeline.
Step 5: Hidden Traps
Even a “perfect” dossier can be stalled by small administrative issues:
- Missing courier label code (Nepal)
- Unacknowledged payment receipt (Uganda)
You did everything right, but your file still doesn’t move. Why? Because execution matters as much as content.
Final Step: Don’t Let It Turn Into a 9-Month Nightmare
Your dossier is more than paperwork — it’s your product’s passport.
A flawless submission isn’t just desirable; it’s essential.
Before you send your file off to regulatory agencies, let an expert pair of eyes review it.
Want a second opinion before submission?
We offer quick, expert reviews tailored to African and ASEAN markets.
Send your file or schedule a call today.