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
Quality Management System

Our Services
Medical device registration:
Cosmetic Products registration:
Public Health Pesticide Registration:
Food Registration:
Animal feed establishments and their products registration
Pharma Products registration
Product Classification- PCS:
DRUG DOSSIER SUPPORT:
ISO : Consultancy, Training and Facilitation for
Quality Management System (ISO 9001)
Telecommunications Quality ( (TL-9000) )
Environmental (ISO 14001)
QUALITY (ISO 9001:2000)
Providing Access TO ISO 17025, ISO 45001 AND HACCP Registration
Corporate Trainings on management techniques
Drug Master File-- DMF
Packaging Material DMF &Excipients
Regulatory Medical Writing:
ISO 15378 Consultant: Benefits of ISO 15378 Certification
Implementing ISO 15378 Standard
Gap Analysis
Getting Certification Ready
Closing Audit Non Compliance
Designing , Layout, and Documentation- Green Field Projects
CTD Publishing & Submission Services
TFA dossier writing Support for SFDA approvals:
A medical device technical file is a summary document prepared for a manufacturer in a clear, well-organized, readily-searchable, and unambiguous manner to demonstrate the safety
and performance of a specific device.
Complete TFA will be built for all class I, II and III of Medical device
Clinical Evaluation Report (CER)
PMCF plan for Fillers as per SFDA
We Pharmaceutical Consultants can help you
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:
SFDA Registration
Importation and custom clearance support
Logistic support
Warehousing support
Market research for distributor
Address
Riyadh, Kingdom of Saudi Arabia