Small US-based speciality company focused on developing medicines for rare genetic diseases. The products are classed as ATMPs and are gene therapy products for inherited neurological and metabolic syndrome disorders
Acting on behalf of the company as their EU RA Department. Real Regulatory essentially runs all EU activities on behalf of the client
Drive the regulatory portion of the project teams, provide and build required submission documentation with client input, manage all interactions with the EU agencies and drive the strategy for all EU regulatory development
Company is appended on the Real Regulatory EMA SME status to avail of fee incentives. Company has no EU-based legal company entity
ATMP Classifications achieved for 4 products
EU Orphan Medicinal Product Designation achieved for 2 products
Scientific Advice meetings completed with Finland for 1 product & Germany for 2 products
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