أطلق منتجك بنجاح في السوق السعودي بشكل أسرع عبر حلول التسجيل التي تقدمها Bio-Standards للأدوية والأجهزة الطبية.
دولة
تأسست شركة المقاييس الحيوية (Bio-Standards) في عام 2010 كممثل تنظيمي متخصص في تسجيل المنتجات لدى الهيئة العامة للغذاء والدواء السعودية (SFDA) والوصول إلى الأسواق المحلية للمصنعين العالميين للأجهزة الطبية والأدوية.
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.
منتج
مصنع
دولة
سنة من الخبرة
مشروع تم إنجازه
نقدم لك فريق من المتخصصين ذوي الخبرة في التنظيمات المحلية، ومعرفة واسعة بلوائح الهيئة العامة للغذاء والدواء السعودية.
استشاراتنا مصممة خصيصاً لمنتجاتك، وندعمك في كل خطوة حتى بعد الحصول على التصنيف والتسجيل والموافقات المحلية.
نحن نؤمن بأن رحلتك لا تقتصر فقط على تلبية المتطلبات العامة؛ نحن نساعدك على الانطلاق في سوق الرعاية الصحية في المملكة.
تواصل مع فريق Bio-Standards واكتشف حلولنا الإستراتيجية التي تساعدك في إطلاق منتجك بدون صعوبات.
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
It has been three years since we decided to hand over all the regulatory busines to Bio-Standards. I believe this was the right decision due to the good reputation of Bio-Standards Company, good performance, a caring team, and wide experience in this field.
Amrit Gill
Allengers
This is to certify that the services provided by BIO-STANDARDS LLC, AL RIYADH, Kingdom of Saudi Arabia, towards SFDA registration of our products are good and satisfactory. We appreciate their efforts for registering our products in the quickest possible time.
Frank Rooijakkers
KANEKA PHARMA EUROPE NV
Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents and/or content needed for successful registration of our products on the Saudi market. Much appreciated.
Yan
PMLS Upstream Marketing Department of Mindray
"We are eager to continue our collaboration with your company. The work you did last year was outstanding, and we are grateful for it!"
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