Global Reach, Local Compliance.

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Rare diseases affect families worldwide, often requiring a global approach to development and access, which is where Regal Laboratories, Regal Technologies, and Regal Technology Partners play a crucial role.

Our international expertise at Regal Laboratories is dedicated to helping our non-profit and academic partners navigate complex regulatory landscapes, in collaboration with Regal Technologies and our Regal Technology Partners.

At Regal Laboratories, we cover key regions, facilitating the journey of vital treatments to patients, wherever they may live, in collaboration with Regal Technologies and our trusted Regal Technology Partners.

At Regal Laboratories, we streamline the pathway to US market access for rare disease therapies by expertly navigating FDA requirements. Our support encompasses crucial submissions for rare diseases, including Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), Humanitarian Device Exemption (HDE), and the use of expedited programs such as Accelerated Approval, Fast Track, Breakthrough Therapy Designation (BTD), and Regenerative Medicine Advanced Therapy (RMAT). Regal Technology Partners provides guidance on standard submissions (510(k), IDE/PMA, IND, NDA, BLA) for drugs, biologics, devices, and advanced therapies, ensuring meticulous preparation and eCTD compliance to accelerate review timelines. Regal Technologies is committed to optimizing these processes to facilitate quicker access to vital treatments.

At Regal Laboratories, we assist our partners in confidently navigating the evolving European regulatory landscape. Regal Technologies offers comprehensive support for EMA pathways essential for rare diseases, including Orphan Drug Designation (ODD), Priority Medicines (PRIME), Conditional Marketing Authorisation, and Authorisation under Exceptional Circumstances. Our experts provide guidance on Clinical Trial Applications (CTA) and Investigational Medicinal Product Dossiers (IMPD), ensuring compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This includes addressing specific challenges and guidance related to orphan medical devices, facilitating seamless access for rare disease patients across the EU/EEA in collaboration with our Regal Technology Partners.

At Regal Laboratories, we assist our partners in expanding their reach to patients in the dynamic Asia-Pacific region. Through Regal Technologies, we provide tailored guidance for navigating the diverse regulatory frameworks specifically for rare disease products in key markets: China (NMPA), where we leverage recent technical guidelines, priority review channels, and potential market exclusivity provisions for rare disease drugs; Japan (PMDA), including expertise with pathways like Sakigake designation for innovative therapies; and South Korea (MFDS), Singapore (HSA), Australia (TGA - including its orphan drug program), and New Zealand. Our in-depth knowledge as Regal Technology Partners ensures that strategies align with local requirements to effectively reach patient populations.

At Regal Laboratories, we assist our partners in unlocking access to therapies for rare diseases in key Latin American markets. With the support of Regal Technologies, we provide strategic guidance to navigate the unique regulatory landscapes and varying definitions of rare diseases across the region, including Brazil's ANVISA, Mexico's COFEPRIS, and other countries like Argentina, Costa Rica, and Chile. Our expertise as Regal Technology Partners facilitates compliant market entry, helping to tackle access challenges for rare disease patients in these rapidly growing regions.

Stay ahead in the complex and evolving rare disease environment with Regal Laboratories. Regal Intel provides our partners, including Regal Technology Partners, with timely, actionable intelligence on global regulatory changes specifically impacting rare diseases. This includes new FDA guidances, evolving EMA policies (like those for orphan devices), NMPA initiatives in China, and more. Our targeted intelligence informs strategic decision-making and enables effective navigation of regulatory complexities unique to this field. Wherever your mission leads, Regal Technologies offers the dedicated expertise to help navigate the path forward.