Streamlining Medical Device Global Regulatory Submissions for Faster Go-to-Market
Syrma Johari MedTech provided end-to-end support to a leading MedTech company to accelerate multi-country regulatory approvals and achieve faster market entry.Navigating Multiple Regulatory Frameworks Efficiently Without Delaying Market Entry
A U.S.-based ophthalmic optics leader sought to rapidly expand its product reach across multiple international markets. With each country demanding unique documentation formats, timelines, and submission procedures, the regulatory complexity threatened timely commercialization.
To address these challenges, the company partnered with Syrma Johari MedTech, leveraging our deep expertise in Quality Assurance and Regulatory Affairs (QA/RA) and proven success in global regulatory submissions for medical devices. Our regulatory specialists developed and executed a comprehensive multi-country submission strategy, supporting the client across all critical stages.
Our end-to-end global submissions solution enabled faster approvals and strengthened the client’s competitive position in the ophthalmic device segment.
Key Outcomes
• 80+ international markets covered as part of the global submissions project
• 6–8 weeks of average dossier preparation and submission time per country
• 100% compliance with regional regulatory timelines
Streamline Your Global Regulatory Submissions with Syrma Johari MedTech
Syrma Johari MedTech brings extensive expertise in global regulatory submissions to help medical device manufacturers minimize delays and fast-track market access. Our team of regulatory specialists provide end-to-end registration support for major markets, including US FDA (510(k), De Novo, PMA), EU MDR/IVDR, CE marking, CDSCO (India), MHRA (UK), TGA (Australia), PMDA (Japan), and 150+ additional markets.