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Technology Progress (Regulatory Affairs)

We thrive to support as being a sublime partner in providing the consultancy across the MENA region to secure market access. Our highly skilled experts tend to offer exceptional support in regulatory affairs, weather your products are medical devices, IVDs, or cosmetics our experts are specialized in providing the support in fulfilling the requirements.

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We endeavor through high quality professionalism to design and implement high-value solutions and low risk and cost-effective end-to-end technology services that fulfill organizational objectives and expectations.

Our solutions are compliant with industry trends, leading industry standards, and best practices. Our teams are globally certified & seasoned experts from various horizons and domains; committed to providing high-end quality solutions.

Technology Progress Enterprise Advisory Services are centered around technology and management .

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Digital transformation

Digital Transformation Strategy
for Competitive Advantage

IT planning

Strategic IT Planning and
Roadmap Development

Technology Solutions

Technology Solutions and
Platforms Selection/Development

Enhance Enterprise

Enhance Enterprise Business,
Services, and Data Architecture

IT

Organizational IT Assessment
(Technology Risk and Compliance)

Technology ROI

Improve Technology ROI Invest in
and Adopt the Right Technology

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Solutions

Our Services

In the Kingdom of Saudi Arabia, the SFDA is a regulatory body responsible for ensuring the quality of medical devices, cosmetics, etc. The SFDA sets rigid standards to protect public health and facilitate market access for innovative products.

SFDA regulates the classification, registration, and post-market surveillance of medical devices to ensure they meet national and international standards for effectiveness and safety, a process fulfilled through the GHAD Portal.

MDEL

Registering the manufacturer’s site with Saudi FDA.

MDMA

The service supports fulfilling the requirement of obtaining the license with Saudi FDA for securing Medical Device Marketing Authorization on behalf of the manufacturer.

Communication with Regulator

Keeping manufacturers updated by liaising with Saudi FDA regarding any updates or changes in the products, process, and requirements.

Classification of Products

Fulfilling the requirement by classifying the products with the Saudi FDA.

Post Marketing Support

Engaging our experts to assist manufacturers with vigilance reporting and post marketing.

MDNR

Providing service by assisting local companies with medical device national registration with the Saudi FDA.

Our Services

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contact

info@tpquest.com

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