WafaCare Regulatory Affairs Consultancy

About Us

“Wafacare Regulatory Affairs Consultancy” is a dynamic full-service Healthcare consultancy with its office at Riyadh, Saudi Arabia which acts as a calculated and profitable supplier to the healthcare/pharmaceuticals/ research/ academic organization in Middle East region by providing them with an excellence services by using over years of sustained strong local and international knowledge.
Our Consultancy provides all kinds of regulatory affair services to our clients in both pharmaceutical and health care fields. We specialize in preparing and handling all kinds of regulatory submissions for Saudi FDA.

Mission

To regulate Medical device, Food, Drug, and Cosmetics via consultation services that we offer in all field of registering the varied products in KSA based upon SFDA approvals. To be number one Authorize representative for medical device foreign manufacturers in KSA. As well as providing logistic support for intended companies. This mission is carried out by expert regulatory team.

Our Services

Medical device registration:

New user account in ghad.sfda.gov.sa
MDEL-Medical Devices Establishment Licensing
AR- Authorized Representative
MDIL- Medical Devices Importing License System
MDMA-Medical Devices Marketing Authorization TFA submission
MDC-Medical Device Classification
MDNR low risk for class 1 nonsterile non-measurable devices

Cosmetic Products registration:

New user account in ecosma.sfda.gov.sa
New Warehouse License
Foreign Manufacture Notification
product notification/registration

Public Health Pesticide Registration:

New user account in pnrapp.sfda.gov.sa
Product registration
Product advertising approval

Food Registration:

New user account in frcs.sfda.gov.sa
Product registration
We provide additional supportive service of addition or changes in artwork according to SFDA requirement to register the product.

Animal feed establishments and their products registration

New user account in afnr.sfda.gov.s
Establishment registration
Product registration
Product renewal
Import of non-medicated feed

Pharma Products registration

New user account in denr.sfda.gov.sa
Submission of Dossier for health, herbal and Hyaluronate products in CTD format
Pharmaceutical companies’ registration
We register Pharmaceutical companies and their products in SFDA

Product Classification- PCS:

Drug
Food
Medical device
Cosmetics

Authorize Representative for Medical Device Manufacturers/suppliers:

Every Foreign company in KSA need a local authorize representative to represent them in SFDA. Being a Authorize representative we can provide complete vigilance support for medical device in the market along with regulating services of the products in SFDA. The manufacturer will have more market to provide their products to any distributer in the kingdom rather getting fixed to a particular. Our service provides a better market for the manufacturers as we also provide logistic support for their product.

Following Services are Provided:

9

SFDA Registration

9

Importation and custom clearance support

9

Logistic support

9

Warehousing support

9

Market research for distributor

Contact Us

 Mobile No :  

+966 50 554 5981

+966 11 4916098

Fax No :  

+966 11 4918643

Address

Riyadh, Kingdom of Saudi Arabia

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