MPCC provides regulatory affairs services to all clients in pharmaceuticals/healthcare fields, and assist
them at each step of the specific regulatory process to manage their timely launch of pharmaceuticals,
Cosmetics, food products and medical devices in the KSA and GCC.

We evaluate information and material to ensure that it is complete and of suitable quality to be
submitted to the authorities.

Prepare the requirements for submissions in CTD, NeeS and eCTD format based on Authorities
requirements and regulations

We submit and follow-up the Registration files until getting the approval for the following:

• Drug products; NCE, Biologics Radiopharmaceuticals, generics and OTC products
• Herbal products and Food supplements
• Veterinary products

We offer post registration services:

• Renewal of Marketing Authorization
• Post-approval changes (Variations)

MPCC values its customers and provides all its expertise and efforts to ensure their products be
registered at SFDA.

We classify the products so the companies can determine whether their products are registered or not
according to classification guideline.

Mesned pharma Consult Center, MPCC is a regional leading medical device consultancy firm, offering a
range of services in Medical Devices Management System, including a full spectrum of regulatory affairs.
Assisting the local companies to register the Low-Risk Medical Devices in Saudi Food & Drug Authority
(SFDA) and Getting their Establishment License. Registering the Authorized Representative, and Getting
Marketing Authorization for the medical device. We classifying products as well as Getting the importing
& exporting permission from SFDA.

We have proven regional expertise, provide comprehensive solutions, focus on robust services that
makes us a trusted leader in Medical Device Services.

MPCC provides Medical Device Certification:

• • Initiate ISO 13485:2016 Certificate that is approved by Saudi FDA
  • Prepare QMS documentation system according to ISO 13485:2016
  • The organization data is recorded on the certification body (IAF) website, immediately upon receipt of an electronic copy of the certificate

Whatever your plan of operating a food business, We know that you need to adhere to the regulatory
requirements, and meet the local standard, we are here to map out your strategic plan and provide
you with the verification you need. At Mesned Pharma Consult Center”MPCC” Food Department, we
offer professional service with a high level of transparency, that gives you the assurance that your
business and products comply with the existing SFDA regulations.

We provide food services as well as consultations that will speed up the process to achieve your goals to
operate your business in Food Registration and related regulatory requirement.
Our specialist team, have a wide range of experience, makes our company acts as a bridge between your
company and SFDA to make sure that your food business meets the required regulations.

MPCC provides companies with the most suitable and effective approach to achieve their goals
Throughout our expertise in the registration of products. We cover Animal Feed Registration & Pesticide
Registration. Our robust registration services involve: Local Establishment Licensing., Warehouse
Licensing, Products Registration, update & renewal file, as well as clearance permission for Animals Feed
Only.

Our regulatory services provide vital support in Cosmetic Registration includes: Local Establishment
Licensing, Warehouse Licensing or Local Manufacture Licensing as well as Products Registration, update
& renewal file