Zelmic AB Information

Zelmic – Experts in Topical Drug Development Zelmic is a specialized CRO and CDMO based in Lund, Sweden, at the heart of Medicon Valley – one of Europe’s leading life science hubs. We are unique in focusing exclusively on topical pharmaceuticals – creams, gels, ointments, solutions, and lotions. Our mission is simple: to provide fast, flexible, and science-driven support to biotech and pharma companies worldwide developing innovative and generic topical drugs. With our GMP manufacturing facility and MIA license, we provide EU-compliant clinical trial material (CTM) manufacturing and importation, ensuring a seamless path to First-in-Human and beyond. Our core expertise: -Formulation development – from pre-formulation and excipient screening to optimization of creams, gels, and ointments -Analytical development and validation – including ICH stability studies, forced degradation, method development & GMP QC testing -Performance testing (IVRT & IVPT) – bioequivalence and skin penetration studies for both innovative and generic topical drugs -CMC & regulatory support – IMPD preparation, EU guidance, and QP release. -Reverse engineering & reformulation – deformulation, scale-up, and tech transfer for topical generics -GMP manufacturing & importation (MIA licensed) – small-scale and clinical trial batches produced and imported under EU GMP Why Zelmic? -100% focus on topical drug delivery – no distractions, only deep expertise -Based in Lund, Sweden (Medicon Valley) – connecting Nordic biotech with global pharma -Fast, flexible, and personal – unlike larger CROs/CDMOs, we adapt to your needs -Integrated CRO + CDMO offering – seamless path from R&D to clinical supply -MIA licensed – ensuring EU-compliant manufacturing, importation, and QP release