Major Service Markets:
- Governmental and private hospitals
- Regulatory heath authorities
- Retail pharmacies
- Medical and non-medical warehouses
- Pharmaceutical companies
- Pharmaceutical manufacturers
- Universities
- Medical products establishments
- Cosmetic product establishments
- Medical devices products establishments
- Food products establishments
Scope of services:
- Products services:
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- Drug products related Services:
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- Study product compliance to SFDA regulations and modifications required
- Products classification in SFDA
- Pharmaceutical products registration
- CTD Files preparation, revision and evaluation
- Labeling requirements and compliance
- Pricing and Re-pricing systems
- Variations in in-active ingredients, outer package, and leaflet
- New products for exclusive agency
- Herbal products related Services:
-
- Study product compliance to SFDA regulations and modifications required
- Products classification in SFDA
- Herbal products registration
- CTD Files preparation, revision and evaluation
- Labeling requirements and compliance
- Variations in in-active ingredients, outer package, and leaflet
- New products for exclusive agency
- Complementary supplements products related Services:
-
- Study product compliance to SFDA regulations and modifications required
- Products classification in SFDA
- Complementary supplements products registration
- CTD Files preparation, revision and evaluation
- Labeling requirements and compliance
- Variations in in-active ingredients, outer package, and leaflet
- New products for exclusive agency
- Veterinary products related Services:
-
- Study product compliance to SFDA regulations and modifications required
- Products classification in SFDA
- Veterinary products registration
- CTD Files preparation, revision and evaluation
- Labeling requirements and compliance
- Variations in in-active ingredients, outer package, and leaflet
- New products for exclusive agency
- Cosmetic products related Services:
-
- Study product compliance to SFDA regulations and modifications required
- Products classification in SFDA
- Labeling requirements and compliance
- Cosmetic products clearance
- New products for exclusive agency
- Medical Devices related Services:
-
- Medical devices listing in MDNR system
- Medical Devices Authorized Representative
- Medical Devices registration in MDMA system
- Medical Devices Importing License MDIL system
- Medical devices clearance
- New products for exclusive agency
- Food products related Services:
-
- Study product compliance to SFDA regulations and modifications required
- Products compliance to SASO and GCC regulations
- Food products clearance
- Establishment services:
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- Drug / Herbal / Complementary Supplement / Veterinary Establishments:
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- Establishments registration in SFDA DENR system
- Drug application in SDR system
- IBRCS system
- Consultation for new products and agencies
- Pharmacovigilance SOP's and reports
- Data Logger online solutions for shipments
- Stuff training to SOP's and all SFDA regulations
- Providing agencies for new establishments
- SOP's for all SFDA activities
- Medical Devices Establishments:
-
- Establishments registration in SFDA MDNR system
- Establishments registration in SFDA MDEL system
- Authorized Representative registration in SFDA MDEL system
- Establishments registration in SFDA MDNR system
- MDIL system
- MDMA system
- SOP's for all SFDA activities
- Consultation for new products and agencies
- Data Logger online solutions for shipments
- Stuff training to SOP's and all SFDA regulations
- Providing agencies for new establishments
- Premises services:
-
- Warehouses inspection and SOP's
- Warehouses registration in SFDA
- cGMP inspection for pharmaceutical plants
- Pharmaceutical plants registration in SFDA
- Cosmetic plants registration in SFDA
- Veterinary plants registration in SFDA
- Authorized representative for medical devices products
- Cosmetic plants registration in SFDA
- Quality services:
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- Full training and SOP's for all SFDA systems and requirments
- Canadian accreditation for hospitals
- ISO 9001 accreditation
- cGMP training and compliance