About Us
Who are we
intelligent Regulations are Medical (ISO 13485:2016 certified) independent Authorized Representative and Medical Devices Regulatory Service provider in Saudi Arabia, our organization is a KSA licensed Authorized Representative Company and it operated by a highly experienced team expert in (Saudi Food & Drug Authority).
Our mission
To help customers achieve their business objectives by providing differentiated consultation and services to help them achieve their aspirations.
Our vision
Becoming the best regulatory affairs expert service in Saudi Arabia
Our values
· Integrity & Transparency
· Technical Precision
· Client–First Approach
· Regulatory Excellence
· Speed Without Compromise
· Long–Term Partnership
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
Why IRME
Why Choose Intelligent Regulations?
Six reasons why leading manufacturers choose IRME as their Saudi regulatory partner
15+ Years of SFDA Expertise
No generalists. Every team member is a
dedicated SFDA specialist — built
through years of hands–on experience.
ISO 13485:2016 Certified
We operate under the same quality
standard we help clients achieve —
rigorous, consistent, auditable.
Global Reach, Locally Grounded
Serving manufacturers from 50+
countries while operating from the heart of Riyadh
15+ Years of SFDA Expertise
Streamlined processes, proprietary
templates, and SFDA relationships enable faster submissions
ISO 13485:2016 Certified
A named Project Manager assigned to
every client — one contact who knows
your portfolio.
Global Reach, Locally Grounded
Medical Devices. Pharmaceuticals.
Food. Three sectors, one partner — one
regulatory strategy.
Quality
Our Quality Commitment
ISO 13485:2016
CERTIFIED
The international standard for quality
management systems in the medical
device sector — the same standard we
help our clients achieve. Our operations
are fully aligned, documented, and
auditable
Documented Processes
Every service governed by written SOPs — ensuring consistency and auditability across all engagements.
Rigorous Review
All technical files and dossiers undergo multi–level internal review before SFDA submission.
Confidentiality
Every engagement protected by a formal NDA. Your data, IP, and strategy — always secure.
Compliance-First
Advice always grounded in current SFDA framework — never assumptions or shortcuts
Continuous Improvement
Ongoing training, regulatory intelligence, and process optimization to stay ahead.
PARTNERSHIP
The IRME Master Partnership Program
Six reasons why leading manufacturers choose IRME as their Saudi regulatory partner
Weekly Regulatory Consultation
Up to 1 hour per week — ongoing advisory on all SFDA matters
Flexible Man-Day Pool
For technical file reviews, gap assessments, and submission
preparation
Portfolio Mapping & Strategy
Regulatory pathway planning for your entire product range
Priority Project Handling
All MDMA and AR projects handled with priority status
Preferential Pricing
15% discount on standard fees for all services during the contract
period
Dedicated Senior Manager
A named Senior Regulatory Affairs Manager assigned to your
account
Contact us today to design a Master Partnership that fits your regulatory needs.
REGULATORY INTELLIGENCE
We Keep You Ahead of Regulatory Change
Proactive intelligence — not reactive scrambling. SFDA changes affect your business; we ensure you are always prepared.
Continuous SFDA Monitoring
Our team continuously monitors SFDA
circulars, guidance documents, and
regulatory updates across all three
sectors.
Proactive Client Notifications
We proactively notify clients of
regulatory changes that may affect their
registered or pending products
Regulatory Impact Assessments
For significant SFDA changes, we
provide detailed impact assessments
and strategic recommendations.
GCC Regulatory Network
Access to our regulatory intelligence
network across the GCC — ensuring you
benefit from regional insights
Training & Awareness
Regular updates, briefings, and training
sessions to keep your team informed on
SFDA requirements
Global Reach, Locally Grounded
Strategic advice on adapting to
regulatory changes with minimal
disruption to your market access.
CLIENT VOICES
What Our Partners Say
“IRME’s team demonstrated exceptional
knowledge of SFDA requirements. Their
guidance was instrumental in achieving our
MDMA approvals efficiently and without
delays. We could not have navigated the
Saudi regulatory landscape without them.“
International Medical Device Manufacturer
Europe
“The dedicated project management
approach at Intelligent Regulations made a
complex multi–product registration feel
seamless. We always knew exactly where
we stood, and every commitment was
delivered on time.
Medical Device Distributor
Kingdom of Saudi Arabia
“IRME’s team demonstrated exceptional
knowledge of SFDA requirements. Their
guidance was instrumental in achieving our
MDMA approvals efficiently and without
delays. We could not have navigated the
Saudi regulatory landscape without them.“
Biotech Company
Asia–Pacific
OUR COMMITMENT
More Than a Service Provider — A Strategic Partner
At Intelligent Regulations, we believe that the best regulatory outcomes are achieved through genuine
partnership. We do not simply process applications — we invest in understanding your business, your products,
and your strategic goals. Every certificate delivered represents a shared success.
Transparency
You are always informed — no surprises,
no hidden fees. Clear communication at
every stage of every project.
Accountability
We own our commitments and deliver
on them. If challenges arise, we address
them proactively and honestly.
Accessibility
Your dedicated manager is always
reachable — by phone, email, or
WhatsApp. We are here when you need
us.
Long-term Thinking
We build relationships, not transactions.
Our success is measured by your
sustained market presence in KSA.
Shared Success
Your market access is our measure of
achievement. We celebrate every SFDA
approval as a joint victory.
CREDENTIALS
Certifications & Credentials
The formal foundations of our authority, trustworthiness, and regulatory standing
ISO 13485:2016 Certified
International quality
management standard for
medical device organizations.
Our operations are fully
aligned — the same standard
we help our clients achieve.
SFDA-Licensed Authorized Representative
Fully licensed by the Saudi
Food and Drug Authority to
act as AR for overseas medical
device manufacturers in the
Kingdom of Saudi Arabia.
Saudi Commercial Registration
Registered Saudi business
entity (C.R. 1010635793) —
providing full legal standing
and accountability for all
regulatory activities.
GCC Regulatory Network
Active participation in GCC
regulatory networks and
professional associations —
keeping our team at the
forefront of regional
regulatory developments.
CREDENTIALS
Certifications & Credentials
The formal foundations of our authority, trustworthiness, and regulatory standing
ISO 13485:2016 Certified
International quality
management standard for
medical device organizations.
Our operations are fully
aligned — the same standard
we help our clients achieve.
SFDA-Licensed Authorized Representative
Fully licensed by the Saudi
Food and Drug Authority to
act as AR for overseas medical
device manufacturers in the
Kingdom of Saudi Arabia.
Saudi Commercial Registration
Registered Saudi business
entity (C.R. 1010635793) —
providing full legal standing
and accountability for all
regulatory activities.
GCC Regulatory Network
Active participation in GCC
regulatory networks and
professional associations —
keeping our team at the
forefront of regional
regulatory developments.
THE IRME ADVANTAGE
The IRME Advantage at a Glance
|
Service Capability
|
IRME
|
Typical Competitor
|
|---|---|---|
|
ISO 13485:2016 Certified Operations
|
|
|
|
SFDA-Licensed Authorized Representative
|
|
|
|
Dedicated Project Manager per Client
|
|
|
|
Full-Spectrum: Medical Devices + Pharma + Food
|
|
|
|
15+ Years Hands-On SFDA Experience
|
|
Partial
|
|
Serving 50+ Countries Globally
|
|
Partial
|
|
Master Partnership / Retainer Program
|
|
Partial
|
|
Post-Market Surveillance & PMS Support
|
|
|
|
UDI / Saudi-DI Registration Capability
|
|
|
|
eCTD Pharmaceutical Submission Expertise
|
|
|