Hometemp | Wafacare

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:

A. New user account in ghad.sfda.gov.sa
B. MDEL-Medical Devices Establishment Licensing,
C. AR- Authorized Representative,
D. MDIL- Medical Devices Importing License System,
E. MDMA-Medical Devices Marketing Authorization TFA submission
F. MDC-Medical Device Classification

Public Health Pesticide Registration:

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

Animal feed establishments and their products registration

A. New user account in afnr.sfda.gov.s
B. Establishment registration
C. Product registration
D. Product renewal
E. Import of non-medicated feed

Cosmetic Products registration

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

Food Registration:

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

Pharma Products registration

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

Product Classification- PCS:

A. Drug
B. Food
C. Medical device
D. 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.