الأدوية

تواجه تعقيدات في تسجيل الأدوية في السوق السعودية؟ Bio-Standards هي دليلك الموثوق به.

تنظم الهيئة العامة للغذاء والدواء السعودية (SFDA) بشكل صارم كل ما يتعلق بالمنتجات الصيدلانية في المملكة، بدءًا من التسجيل وحتى التسويق. ورغم أن عملية التسجيل ضرورية للوصول إلى الأسواق، فإنها يمكن أن تكون معقدة وتستغرق وقتا طويلا، وتستمر لأشهر أو حتى سنوات.

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Bio-Standards تسهل رحلتك

يتمتع مستشارونا بالفهم العميق والخبرة اللازمة للتعامل مع متطلبات الهيئة العامة للغذاء والدواء بسلاسة. نحن نقدم خدمات:

- الدعم الشامل: من الطلب الأولي إلى الموافقة النهائية.

- تبسيط العمليات: تقليل التأخير وزيادة الكفاءة.

- الخبرة التنظيمية: ضمان الامتثال لجميع لوائح الهيئة العامة للغذاء والدواء.

- التواصل الواضح: إبقائك على علم وتمكينك طوال الوقت.

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ركز على الابتكار، ودع Bio-Standards تتولى الباقي

الشراكة مع Bio-Standards تعني:

- تقليل المخاطر وتجنب المضاعفات المحتملة.

- توفير الوقت والموارد الثمينة.

- الوصول إلى سوق الأدوية السعودية بثقة.

الجدول الزمني

الصلاحية

تجديد / تحديث نظام تصنيف المنتجات (PCS)

تواجه تعقيدات في تسجيل الأدوية في السوق السعودية؟ Bio-Standards هي دليلك الموثوق به.

‍

Bio-Standards تسهل رحلتك

- الدعم الشامل: من الطلب الأولي إلى الموافقة النهائية.

- تبسيط العمليات: تقليل التأخير وزيادة الكفاءة.

- الخبرة التنظيمية: ضمان الامتثال لجميع لوائح الهيئة العامة للغذاء والدواء.

- التواصل الواضح: إبقائك على علم وتمكينك طوال الوقت.

‍

ركز على الابتكار، ودع Bio-Standards تتولى الباقي

الشراكة مع Bio-Standards تعني:

- تقليل المخاطر وتجنب المضاعفات المحتملة.

- توفير الوقت والموارد الثمينة.

- الوصول إلى سوق الأدوية السعودية بثقة.

Timeline

Validity

Renewal / Update

تواصل مع فريقنا

"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

الأدوية

الجدول الزمني

الصلاحية

تجديد / تحديث نظام تصنيف المنتجات (PCS)

Timeline

Validity

Renewal / Update

خدماتنا

المنتجات الصحية والعشبية

المنتجات الدوائية

المنتجات الدوائية

المنتجات الصحية والعشبية

"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

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

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

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

"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

"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

"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'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

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

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

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

"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

"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

"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'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

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

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

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

"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

"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

"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'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

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

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

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

"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

"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

"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