Regulatory & Quality · Regulatory Affairs
Registration, on a transparent timeline.
An experienced regulatory team that clears obstacles, keeps communication constant, and never lets a promised date pass quietly.
Every dossier, Common Technical Document (CTD) format, complete with bioequivalence and stability data, is handled by a team that has run this process many times before, and knows where approvals tend to stall and how to keep them moving. We keep communication proactive and honest, and we hold ourselves to the timelines we give you.
Our Registration Process
1
Dossier Preparation & Gap Analysis
Supplier prepares the dossier, our regulatory team reviews it, and sends back a gap analysis while the review is underway so fixes start early
2
Closing the Gap & Submission
Once flagged gaps are closed, the dossier is submitted for formal regulatory screening
3
Review & Query Response
Our team's hands-on experience with each market's process shortens query turnaround
4
Registration Granted
Supply planning with channel partners begins immediately
Governance
Compliance sits alongside commercial teams in every evaluation, never downstream of it.
No category gets a pass on regulatory or manufacturing quality oversight, whatever its market size or margin. A regulatory affairs representative sits in on every VAIS™ evaluation committee meeting, with the standing to pull any candidate from consideration regardless of how well it scores commercially. Every governance decision is written down and open to review, we don't make quiet exceptions.
Regulatory Marks We Hold
NPRA
National Pharmaceutical Regulatory Agency (Malaysia)
HSA
Health Sciences Authority (Singapore)
NMRA
National Medicines Regulatory Authority (Sri Lanka)