Our Process
Our process
From First Contact to MDMA Certificate
A structured, transparent 7–step journey — managed end–to–end by our expert team
Initial Consultation
1
AR Appointment
2
Document Collection
3
Dossier Preparation
4
SFDA Submission
5
Query Management
6
Certificate & Post-Market
7
Initial Consultation
Portfolio
assessment, device
classification,
regulatory pathway
& bundling strategy
AR Appointment
AR agreement
execution and
formal SFDA
registration on your
behalf
Document Collection
Detailed checklists;
technical
documentation
reviewed against
SFDA requirements
Dossier Preparation
Complete, SFDA–
ready submission
dossiers compiled
for each application
SFDA Submission
Electronic
submission via
GHAD; all post–
submission
communications
managed
Query Management
Expert responses to
SFDA queries and
deficiency letters —
on time, every time
Certificate & Post-Market
MDMA certificate
delivery and
ongoing post–
market compliance
suppor