Navigate regulatory requirements across international markets
RIAR Consulting supports regulated manufacturers and life-sciences organisations with regulatory planning, submission preparation, compliance and market-entry support across selected international markets.
Our regulatory experience includes
Expanding into international markets requires more than understanding local registration requirements. It requires a clear regulatory strategy, appropriate technical documentation and an understanding of the authorities and conformity assessment processes involved.
- Saudi Arabia — Saudi Food and Drug Authority (SFDA)
- United States — US Food and Drug Administration (FDA)
- European Union — EMA for applicable medicinal-product procedures; European Commission, national competent authorities and notified bodies for relevant medical-device and IVD requirements
- India — Central Drugs Standard Control Organisation (CDSCO)
- United Kingdom — Medicines and Healthcare products Regulatory Agency (MHRA)
Our approach is tailored to the product, regulatory classification, target market and applicable submission pathway. Authorities, notified bodies and local representatives each play a distinct role; the support available depends on the product category and jurisdiction.
Five authorities, one route map
Regulatory pathway by product category
Indicative pathways only. Each product is assessed on its classification, target market and submission route; timelines are estimated per product and are not guaranteed approval periods.
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Saudi Food and Drug Authority, Riyadh
Book a call about this route- Medicines
- Drug registration (CTD/eCTD)
- Devices
- MDMA licence
What RIAR does
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U.S. Food and Drug Administration, Silver Spring
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- NDA, ANDA, BLA or IND
- Devices
- 510(k) or De Novo
What RIAR does
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European Medicines Agency, Amsterdam, with EU notified bodies for devices
Book a call about this route- Medicines
- Centralised, DCP, MRP or national
- Devices
- EU MDR, CE marking
What RIAR does
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Central Drugs Standard Control Organisation, New Delhi
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- New drug, import or manufacturing permission
- Devices
- Import or manufacturing licence
What RIAR does
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Medicines and Healthcare products Regulatory Agency, London
Book a call about this route- Medicines
- Marketing authorisation, national or recognition route
- Devices
- UKCA with UK Responsible Person
What RIAR does
Your regulatory partner for global market expansion
Beyond the US, UK, European Union, India and Saudi Arabia, our regulatory research, strategy, documentation and submission support can cover other regions and national frameworks, subject to product type and applicable local requirements.
- Region
Middle East and GCC
- Saudi Food and Drug Authority (SFDA) – Saudi Arabia
- UAE Ministry of Health and Prevention (MOHAP)
- Emirates Drug Establishment (EDE), where applicable
- Other relevant GCC regulatory authorities
- Region
Asia-Pacific
- Therapeutic Goods Administration (TGA) – Australia
- Health Sciences Authority (HSA) – Singapore
- Pharmaceuticals and Medical Devices Agency (PMDA) – Japan
- National Medical Products Administration (NMPA) – China
- Relevant ASEAN national regulatory authorities
- Region
Africa
- South African Health Products Regulatory Authority (SAHPRA)
- National Agency for Food and Drug Administration and Control (NAFDAC) – Nigeria
- Other relevant national regulatory authorities across African markets
- Region
Other international markets
- Health Canada – Canada
- Additional country-specific regulatory pathways based on product classification, local legislation and market-entry requirements
Not limited to market access
Alongside regulatory market access, RIAR offers manufacturing intelligence through VERA 2.0: connecting manufacturing signals and critical plant conditions to help identify emerging operational risks, wherever a plant operates.
Tell us the product and the market
A 30-minute call with a regulatory lead. You leave with the likely route, the main risks and the next steps.