رائدون في مجال الاستشارات التنظيمية في السعودية

أطلق منتجك بنجاح في السوق السعودي بشكل أسرع عبر حلول التسجيل التي تقدمها Bio-Standards للأدوية والأجهزة الطبية.

خبرة واسعة ومعرفة شاملة

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.

يمتلك فريقنا معرفة واسعة باللوائح التنظيمية لهيئة الغذاء والدواء السعودية وقدرته العالية على التعامل مع التحديات المعقدة التي قد تواجهك في الامتثال والوصول إلى السوق السعودي، وهذا يساعدنا على إنشاء استراتيجيات شاملة لجميع أصحاب العلامات التجارية الطبية في دخول سلس للأسواق السعودية.في Bio-Standards، نتعامل مع جميع المهام الحساسة بأقصى قدر من الاحتراف والنزاهة والدقة والشفافية.

50,000+

منتج

750+

مصنع

0

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دولة

0

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سنة من الخبرة

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مشروع تم إنجازه

خدمات الاستشارات

لماذا Bio-Standards؟

خبرة عالية ونتائج مثبتة

نقدم لك فريق من المتخصصين ذوي الخبرة في التنظيمات المحلية، ومعرفة واسعة بلوائح الهيئة العامة للغذاء والدواء السعودية.

حلول مخصصة لأجلك، ودعم مستمر

استشاراتنا مصممة خصيصاً لمنتجاتك، وندعمك في كل خطوة حتى بعد الحصول على التصنيف والتسجيل والموافقات المحلية.

فتح آفاق للنمو والتوسّع

نحن نؤمن بأن رحلتك لا تقتصر فقط على تلبية المتطلبات العامة؛ نحن نساعدك على الانطلاق في سوق الرعاية الصحية في المملكة.

اطلب استشارة مجانية

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.
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تواصل مع فريق Bio-Standards واكتشف حلولنا الإستراتيجية التي تساعدك في إطلاق منتجك بدون صعوبات.

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Resource Section

Explore the registration process based on Saudi FDA regulations in the Saudi market with our comprehensive free e-book. We will walk you through the main regulations for bringing medical products to market.

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Yan (D)

Mindray

We are very willing to continue cooperating with your company. Your excellent work, dedicated support, and professionalism last year were appreciated.

Max Zheng

Acon Biotech (Hangzhou) Co.,Ltd.

We truly appreciate all your efforts and sincerely thank your team for the continuous support and cooperation throughout the process.

Charlotte TESTA

Integra LifeSciences Services

Wonderful news! Thank you very much for your excellent support, professional assistance, and help with renewing this application successfully.

Ayman Salama

Semac for medical services

Thank you for your effort and professionalism. We truly appreciate your accuracy, dedication, and the excellent support throughout our collaboration.

Eng. Saad Al Gharman

ALMADAR MEDICAL Co.

For the past three years, we entrusted all regulatory business to Bio-Standards due to their strong reputation, quality service, caring team, and vast

Sami N. Yousef

CenteMed Medical Establishment

We have worked with Bio Standards for years and value their professional, experienced, supportive, and punctual team with strong SFDA expertise.

We are very willing to continue cooperating with your company. Your excellent work, dedicated support, and professionalism last year were appreciated.

Yan (D)

PMLS Upstream Marketing Department

We truly appreciate all your efforts and sincerely thank your team for the continuous support and cooperation throughout the process.

Max Zheng

Regional Sales manager

Wonderful news! Thank you very much for your excellent support, professional assistance, and help with renewing this application successfully.

Charlotte TESTA

EMEA Regulatory Affairs Project Manager

Thank you for your effort and professionalism. We truly appreciate your accuracy, dedication, and the excellent support throughout our collaboration.

Ayman Salama

Executive manager

For the past three years, we entrusted all regulatory business to Bio-Standards due to their strong reputation, quality service, caring team, and vast

Eng. Saad Al Gharman

CEO

We have worked with Bio Standards for years and value their professional, experienced, supportive, and punctual team with strong SFDA expertise.

Sami N. Yousef

Managing Director

We sincerely thank Bio Standards for outstanding registration support, expert solutions, smooth cooperation, and dedication throughout.

Eng. Yasser Salah

Sales Engineer

Special thanks to Bio Standards for excellent registration support, practical solutions, professional guidance, and efficient problem-solving.

Eng. Yasser Salah

Sales Engineer

Bio-Standards is a highly efficient and professional team. This has been a smooth, successful, and valuable cooperation.

Xiaoyun Chen

-

Bio Standards provided responsive, detail-oriented regulatory support that ensured smooth documentation handling and successful Saudi market entry.

Frank Rooijakkers

General Manager Interventional

The Bio Standards team handled our MDMA registration exceptionally well with expert guidance, responsive support, and smooth process completion.

Nooraldin Abo Kamal

Managing director

We certify that BIO-STANDARDS LLC provided satisfactory SFDA product registration services with swift efforts and professional support in Saudi Arabia

Amrit Gill

-

To BIO-STANDARDS LLC, in appreciation of outstanding regulatory consultation services delivered with professionalism, excellence, and timely support.

Dr. Talal AlGhamdi (D)

Director

We thank Bio Standards for their excellent support, professional team, outstanding service, and reliable regulatory and registration expertise.

Dr. Mohammed Shaheen (D)

-

Having registered products in 40+ countries, we consider Bio Standards among the best consultancies for efficient SFDA registration and Saudi market a

Safwan Abdallah (D)

Global Director of Business Development

Working with Bio-Standards has been a pleasure. They provided timely guidance on regulations, kept us updated, and ensured smooth market entry into Sa

Pablo Sanchez

Senior Regulatory Affairs Specialist

Great experience with your team. Professional, timely, and dedicated, with strong understanding of needs and effective solutions.

Mohammed Omer

Business Development Department

Outstanding experience with Bio-Standards. Strong regulatory expertise, efficient execution, clear communication, and reliable support throughout.

Borja Tórtola

International Sales Technician

Bio-Standards shows strong professionalism, reliability, and excellence. Proactive, communicative, and delivers high-quality results that exceed expec

Maher Bannourah

Director

Pleasure working with your team—professional, responsive, and detail-oriented. Smooth, efficient process with strong commitment to quality.

Ali Ghaidan

CEO & Founder

Professional team with strong technical expertise, reliable support, consistent quality service, and trusted long-term cooperation.

Mohammad Alshammari

Founder & CEO

Extremely satisfied with Bio-Standards. Expert, responsive support ensured smooth submissions and helped secure multiple Saudi licenses.

Nicole

Regulatory Affairs Specialist

Professional, reliable support for Saudi market access. Strong expertise, responsiveness, and commitment helped grow our business.

Hiroaki Hashimoto

Senior manager, Regulatory Compliance and Safety

Very positive experience with your team. Professional, responsive, and reliable with smooth communication. We value this partnership.

Joanna Lin

Regulatory Affairs Specialist

Great experience with Bio Standards for SFDA registration. Strong support, excellent service, and Dana Saad’s responsiveness made it smooth.

Perminder Rupra

CEO

Huawei values Bio-Standards’ professionalism and efficiency. With strong support, we met Saudi-FDA requirements and achieved our goals.

Huawei

-

"Outstanding experience with Bio-Standards. Deep expertise, efficient execution, tailored support, clear communication, and dependable service ."

Borja Tórtola

International Sales Technician

"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."

Sami N. Yousef, Managing Director

"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!"

Perminder Rupra, CEO

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.

CEO

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.

Frank Rooijakkers

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.

Amrit Gill

"It's truly a big surprise for us! We really appreciate the effort you all made for this tight project. Thank you very much!"

Jelly , Regulatory Affairs

"We really appreciate all the efforts Bio-Standards has made in assisting Mindray with regulatory affairs in Saudi Arabia. So far, the services provided by Bio-Standards for Mindray have been really nice and professional."

Tracey Hao

"We are eager to continue our collaboration with your company. The work you did last year was outstanding, and we are grateful for it!"

Yan

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