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About hameln rds

Your Trusted Partner in Pharmaceutical Innovation We collaborate with pharmaceutical and biotech companies, as well as visionary startups, to bring life-changing products to market. From high-potency API (HPAPI) development and GMP manufacturing to QC testing, stability studies, and injectable formulation development - we support every step of your journey, including Regulatory Affairs. Our Expertise in high potent as well as conventional APIs and Intermediates - Design, develop, and optimize synthetic routes - Manufacture GMP batches in compliance with EU-GMP and FDA standards - Provide solutions for Nitrosamine challenges in our developed APIs Comprehensive QC & R&D Support We specialize in sterile injectable formulations like ampoules, vials, and prefilled syringes (PFS), offering: - Stability testing under all ICH conditions - Development and Validation of analytical methods according to EP, USP, JP - EU batch release by our certified QP team - Full regulatory submission and lifecycle management Core Competencies - GMP development and manufacturing of APIs and HPAPIs, including controlled substances - Analytical and galenical development of sterile pharmaceutical products - QC and laboratory services - Regulatory Affairs and strategic guidance Specialized Services - GMP production of APIs, HPAPIs, and intermediates - Advanced analytical services: method development, physical/chemical & microbiological testing, stability & photostability studies - Galenic formulation for sterile products with tech transfer to CMOs - EU batch release and quality control for sterile/non-sterile products - Regulatory submissions and ongoing lifecycle management - Long-term project support and proactive partnership Certifications & Compliance GMP-certified for high-potency API production Approved by EMA, ŠÚKL, Health Canada, US FDA, and Korean FDA Licensed for EU testing and release of imported medicinal products We build big things from little Modra.