المنتجات الصحية والعشبية

خدماتنا واستشاراتنا للمنتجات الصحية والعشبية

- نظام ترخيص المنشآت (ELS): الحصول على التراخيص اللازمة للعمل في السوق السعودي.

- تسجيل المستودعات: تأكد من أن مستودعات التخزين الخاصة بك تلبي معايير الامتثال للهيئة العامة للغذاء والدواء.

- تسجيل المنتجات الصحية (HPR): قم بتسجيل منتجاتك الصحية حسب متطلبات الهيئة العامة للغذاء والدواء.

- تسجيل المنتجات العشبية: تأكد من تلبية منتجاتك العشبية لجميع متطلبات اللوائح المحلية.

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لماذا تختار شركة المقاييس الحيوية؟

- الخبرة العميقة: يفهم فريقنا الفروق الدقيقة في لوائح الهيئة العامة للغذاء والدواء الخاصة بالمنتجات الصحية والعشبية.

- تبسيط العمليات: نعمل على تقليل التأخير وزيادة الكفاءة إلى أقصى حد لدخول السوق بشكل أسرع.

- ضمان الامتثال: نحن نضمن أن منتجاتك تلبي جميع متطلبات الهيئة العامة للغذاء والدواء.

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تتيح لك الشراكة مع المقاييس الحيوية ما يلي:

- تقليل المخاطر وتجنب خسائر التأخير.

- توفير الوقت والموارد الثمينة.

- الوصول إلى سوق المملكة العربية السعودية بنجاح.

- البقاء على اطلاع بتحديثات اللوائح مع توجيهات خبرائنا.

الجدول الزمني

تقديم المنتجات الصحية والعشبية: 155 يوم عمل

الصلاحية

صلاحية تسجيل المنتجات الصحية والعشبية وتسجيل المستودع هي خمس سنوات.

تجديد / تحديث نظام تصنيف المنتجات (PCS)

تواصل مع فريقنا
رسوم الهيئة العامة للغذاء والدواء
نوع المنتج رسوم تقديم الملف رسوم تسجيل النظام الإلكتروني لتسجيل الأدوية السعودي (سدر)
المنتجات الصحية والعشبية 20,000 ريال سعودي 4,000 ريال سعودي + ضريبة القيمة المضافة في السعودية

"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

Centennial Medical Establishment

"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

Elipse Health Limited (United Kingdom)

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

ALMADAR MEDICAL

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

Allengers

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

KANEKA PHARMA EUROPE NV

"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

PMLS Upstream Marketing Department of Mindray

"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

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS 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!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"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

Centennial Medical Establishment

"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

Elipse Health Limited (United Kingdom)

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

ALMADAR MEDICAL

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

Allengers

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

KANEKA PHARMA EUROPE NV

"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

PMLS Upstream Marketing Department of Mindray

"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

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS 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!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"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

Centennial Medical Establishment

"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

Elipse Health Limited (United Kingdom)

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

ALMADAR MEDICAL

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

Allengers

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

KANEKA PHARMA EUROPE NV

"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

PMLS Upstream Marketing Department of Mindray

"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

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS 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!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"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

Centennial Medical Establishment

"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

Elipse Health Limited (United Kingdom)

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

ALMADAR MEDICAL

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

Allengers

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

KANEKA PHARMA EUROPE NV

"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

PMLS Upstream Marketing Department of Mindray

"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

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS 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!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd