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

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