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.

Quality Management System

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

DRUG DOSSIER SUPPORT:

Module 1 – Administrative Information
Module 2 – CT Overview
Module 3 – Drug & Product Part /CMC
Module 4 – Non Clinical
Module 5 – Clinical

ISO : Consultancy, Training and Facilitation for

Consulting
Compliance
Certification
System Implementation
Audits
Training

Quality Management System (ISO 9001)

Medical Device Quality ( ISO 13485) )

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

DMF compilation in CTD Format / Country Specific format
Open & close part DMF writing
Review of DMF For Submission
Type II (Active Ingredient) DMF Preparation and submission to US FDA.
European Certificate of Suitability (CEP) submission and Preparation.
Canada Submission & Preparation.
PPC can also help you with Analytical Testing – Elemental Analysis, Validations, Stability, etc

Packaging Material DMF &Excipients

DMF Compilation and Preparation as per requirement of Client
US DMF Type III DMF DMF Submission and Registration for Packaging material. (Example)
US DMF Type IV DMF DMF Submission and Registration for Excipients. (Example)
Quality Audit for Primary Packaging materials Manufacturers
Review and Annual Updates of DMFs
Technical Testing of Primary Packaging Material & Excipients

Regulatory Medical Writing:

Medical writing for Module 5 – Clinical Documentation
Medical Writing for Module 4 – Non Clinical Documentation
Module 2.4 to Module 2.7 – Overview & summaries
PSURs Reports – Periodic Safety Update Report now called PBRER – Periodic Benefit- Risk Evaluation Report
Pharmacovigilance System Setup
Risk Management Plans
Summary of Product ( SPC), Pack Insert

ISO 15378 Consultant: Benefits of ISO 15378 Certification

Assures Implementation of GMP Principals in Manufacturing of Pharmaceutical Packaging Material
Eliminates Risk In Manufacturing and adheres to regulatory requirements
Assures Pharmaceutical Company of QMS Implementation and regulatory compliance
Competitive Advantage over other Non certified suppliers
Symbol of commitment to comply ever changing regulatory requirement
Risk Management and Validation
Batch Traceability

Implementing ISO 15378 Standard

Gap Analysis

Getting Certification Ready

Closing Audit Non Compliance

Designing , Layout, and Documentation- Green Field Projects

GMP Compliant Site

CTD Publishing & Submission Services

Compilation of USDMF in eCTD
Paper to eCTD Conversion services
eCTD Publishing
eCTD Submission service to USFDA, Health Canada, EDQM, EMEA
Filling of US Drug Master Files(DMF Submission),Certificate of Suitability(CEP),TYPE II DMF ,Master Files ,CTD Dossiers
Originals, Amendments, Annual report Submissions, eCTD baseline Submissions, Medical Device Submissions
eCTD Life Cycle Maintenance

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

Implementing ISO 15378 Standard
Gap Analysis
Getting Certification Ready
Closing Audit Non Compliance
Designing , Layout, and Documentation- Green Field Projects
GMP Compliant Site 

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

E-Mail

regulatory@wafacare.com

Contact Now

12 + 15 =