Questions we are asked first

Yes. A manufacturer outside Saudi Arabia needs an Authorised Representative in the Kingdom to hold the registration with SFDA. RIAR acts as that representative and manages the licence on your behalf.

The evidence can. The structure cannot. We write the core content once, then adapt it to each authority’s format, rules and reviewer expectations, so a second market builds on the first instead of starting over.

Thirty minutes with a regulatory lead. You describe the product and the markets; we tell you the likely route, the main risks and a realistic timeline. There is no obligation and no fee.

Yes. Distributors bringing products into a market need the same licences and the same documentation. We handle both sides and keep the manufacturer and the distributor on one plan.

RIAR Consulting provides global regulatory consulting services, including strategy, submissions, approvals and lifecycle compliance, and manufacturing intelligence through VERA 2.0.

We support multiple global markets including SFDA, US FDA, CDSCO, EMA and EU national authorities (with notified bodies for EU MDR devices), and UK MHRA, as well as other international markets.

No. While medical devices are a strong vertical, we also support pharmaceuticals, IVDs, cosmetics, and emerging health technologies.

Yes. We work with manufacturers, distributors, and innovators across regulated life-science sectors.

Yes. We manage the full regulatory lifecycle from strategy and documentation to submission, approvals, and renewals.

We follow authority-specific regulations, guidance documents, and structured workflows to ensure compliant submissions.

Yes. Each project is led by a dedicated regulatory consultant responsible for strategy, execution, and communication.

Absolutely. We help define regulatory pathways, timelines, and documentation requirements for efficient market entry.

Yes. We support renewals, variations, post-market compliance, and ongoing regulatory updates.

You can begin by booking an exploratory call to discuss your requirements and regulatory goals.

Yes. We support pharmaceutical registration with authorities including the US FDA, MHRA, EMA and EU national authorities, CDSCO and SFDA, from pathway assessment and dossier preparation to submission support and query management.

Yes. We prepare, review and compile CTD dossiers and support eCTD submission readiness, covering Module 1 regional requirements and Modules 2–5 as applicable, with consistency and completeness checks before submission.

Yes. We provide GMP documentation review, quality system gap assessment, manufacturing site documentation support and inspection-readiness support, and help coordinate responses to regulatory observations.

We assess country-specific requirements, identify the relevant authority and registration pathway, review documentation for gaps and plan the submission for each target market.

Yes. We assess the regulatory impact of changes to products, manufacturing processes, specifications and packaging, and support the applicable variation submissions.

We support renewals, variations, product information updates, applicable post-authorisation commitments and ongoing documentation maintenance throughout the product lifecycle.

Manufacturing intelligence involves connecting and interpreting operational signals, equipment information and manufacturing conditions to provide better visibility into production environments and support informed operational decisions.

VERA 2.0 is RIAR’s Continuous Intelligence Manufacturing System. It is designed to create a connected view of manufacturing environments, monitor relevant operational signals and provide intelligence to help identify emerging risks.

VERA is designed to help manufacturers understand critical manufacturing conditions, identify abnormal operating patterns and support earlier investigation of potential operational issues.

No. VERA is designed as an advisory intelligence system. It does not directly write to or control plant systems. Operational decisions remain with authorised personnel.

VERA’s integration approach is designed around connecting relevant manufacturing and operational systems. Specific integrations and compatibility are assessed against each customer’s existing infrastructure.

Yes. RIAR brings together regulatory consulting and manufacturing intelligence to support regulated organisations across their regulatory and manufacturing requirements.