WafaCare
Wafacare Regulatory Affairs Consultancy
“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 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 Vision
Achieving customers satisfaction by accomplishing the mission in timely manner.
Our Services
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
Medical device registration
New user account in ghad.sfda.gov.sa
MDEL-Medical Devices Establishment Licensing,
R- Authorized Representative, D. MDIL- Medical Devices Importing License System
MDMA-Medical Devices Marketing Authorization TFA submission
MDC-Medical Device Classification
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 ecosma.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
Our Story
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.
Get Started
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