We can help you launch your product into the Saudi Market faster with our Regulatory Registration Solutions for Pharmaceuticals and Medical Devices.
Countries
Bio-Standards was established in 2010 as a Regulatory Representative specializing in Product Registration with the Saudi Food & Drug Authority (SFDA) and local market access for international manufacturers of Medical Devices and Pharmaceuticals.
Our team has in-depth knowledge of Saudi FDA Regulations and excels at navigating complex challenges to deliver optimal compliance and market access solutions. This allows us to create comprehensive strategies for all stakeholders to achieve seamless entry into the Saudi Market.
At Bio-Standards, we handle all sensitive tasks with the utmost professionalism, Integrity, Accuracy, and Transparency.
Project Completed
Years of experience
Countries
Manufacturers
Products Registered
Our team comprises seasoned Regulatory Professionals with extensive knowledge of the Saudi FDA landscape, ensuring you navigate complexities with ease.
We offer customized consultations and work closely with you, providing you with support in every step of the way to ensure your success.
We go beyond just compliance, unlocking your true potential in the Saudi Healthcare market and fostering sustainable growth.
Schedule a free consultation with our regulatory specialists and discuss your specific needs. We'll tailor a solution to ensure your smooth and successful market entry in Kingdom of Saudi Arabia.
Sami N. Yousef, Managing Director
Centennial Medical Establishment
"We've been with Bio-Standards for years, they're simply the best in the Saudi market. Professional, cooperative, and always meeting deadlines flawlessly. Their expertise with Saudi FDA requirements is unmatched. Highly recommended for medical device companies."
Perminder Rupra, CEO
Elipse Health Limited (United Kingdom)
"We collaborated with Bio-Standards to secure our MDMA Class IIa (Class B) medical devices license. The team's excellent coordination made the process seamless and efficient. We obtained the license within 2 months and the AR license within a few weeks. Looking forward to future collaborations with the Bio-Standards team!"
CEO
ALMADAR MEDICAL
"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."
Frank Rooijakkers
KANEKA PHARMA EUROPE NV
"Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents or content needed for successful registration of our products on the Saudi market. Much appreciated."
Amrit Gill
Allengers
"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."
Jelly , Regulatory Affairs
NingboSoundway Medical Appliances Co , Ltd
"It's truly a big surprise for us! We really appreciate the effort you all made for this tight project. Thank you very much!"
Staying informed with the most recent updates and announcements through our dedicated blog section.
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