Regulatory consulting firm with SFDA in Saudi Arabia

Regulatory & Product Registration

Regulatory consulting firm specialized in product registration with SFDA and local markets access for international manufacturers of Medical Devices, Pharmaceuticals, Cosmetics, Food, Feeds, and Pesticides.

Match Making

We assists foreign manufacturers and local distributors to find qualified and recognized partner who have mutual interests in the KSA market

Logistics

Our warehouses are SFDA licensed entity fulfilling the latest SFDA requirements for high and low risk products from food, cosmetics, health & herbal products, drugs, and medical devices warehousing.

Latest News

2021-05-01

COUNTRIES

750+

MANUFACTURERS

50000+

PRODUCTS

Testimonials

"We have been dealing with Bio-Standards company for many years. And honestly, we were very lucky to find such a very professional, respectful, cooperative and experienced company who in parallel have a great team and great people who were always at our expectations by being kind enough, very supportive, punctual, very stick to their deadlines and super experts in dealing with Saudi FDA requirements which led to getting excellent services and providing us with the best results in a very reasonable time"
Sami N. Yousef, Managing Director of CenteMed Medical Est.

"I want to show my most sincere appreciation to all of you, and we would never be this fast without your dedication."Zachary Zhang, Lepu Medical Technology (Beijing) Co., Ltd.

"I would say we really appreciate all the efforts Bio-Standards have done for assisting Mindray dealing with the regulatory affairs in KSA and so far the services BS offered for Mindray is really nice and professional."Tracey Hao - SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

"I think we are very willing to continue to cooperate with your company, your work last year is very good, thank you!"Yan, PMLS Upstream Marketing Department of Mindray

"Thank you so much for your support and great business partnership. Dexcom truly appreciates this great opportunity to serve customers in needs."

Dexcom, Regulatory team

"As an international medical company that has registered products in over 40 countries through consultancy firms. I can truthfully say Bio-Standards is one of the best we have worked with. They have a deep understanding of the regulatory agencies in KSA and know the quickest and most efficient pathway for approvals. we have successfully registered six devices with the Saudi FDA through Bio-Standards's services and are currently planning for many more. I confidently and wholeheartedly recommend Bio-Standards to any company looking to register their products in the Kingdom of Saudi Arabia."

Safwan Abdallah, MicroSafe Group DMMC

"Bio-Standards has been very responsive and extremely attentive to detail when it came to the documents and/or content needed for a successful registration of our products on the Saudi market. Much appreciated."

Frank Rooijakkers, KANEKA PHARMA EUROPE NV

"This is to certify that 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 quickest possible time."

Amrit Gill, Allengers.

It's really a big surprise for us! Really appreciate the effort you all made for this tight project! Thank you very much! ( NingboSoundway Medical Appliances Co , Ltd ) - Jelly , Regulatory Affairs

we are very willing to continue to cooperate with your company, your work last year is very good, thank you! Yan (PMLS Upstream Marketing Department) - Mindray

^®Partners in Compliance

رائدون في مجال الاستشارات التنظيمية

أول ممثل مفوض مستقل في المملكة العربية السعودية

نوفر حلول الوصول إلى الأسواق في المملكة العربية السعودية

من الاستيراد، اللوجستيات، تسجيل المنتج، التوفيق بين الموزعين

نمثل وندعم أكثر من 700 مصنع حول العالم

لمجموعة منتجات مختلفة مثل الأدوية، الأجهزة الطبية، الغذاء، مستحضرات التجميل، المبيدات الحشرية والأعلاف