WHERE SCIENCE THRIVES
Zelmic is an experienced, privately held Contract Research Organisation (CRO) in Lund, Sweden focused entirely on the development of topical and transdermal pharmaceutical formulations. Located in one of Europe’s top science hubs – home to numerous life science companies and the site of both the MAX IV laboratory and the United Nations’ newly launched UNOPS Global Innovation Centre – our dedicated team and specialized laboratory are perfectly situated for helping our customers to succeed.
PROVEN track RECORD
Founded in Lund, Sweden in 2002 and led by co-founder and CEO David Sagna, Zelmic has a long track record in developing topical pharmaceutical products and getting them to clinical testing in the most cost effective and safest way. Our team members have been working with drug delivery technologies in different surroundings and have brought both oral, paternal and dermatological products on the market. Every year since our start, Zelmic has taken at least two topical products from idea to clinical or pre-clinical testing. During the same period we have filed numerous patent applications protecting the products in development.
GMP, CMC & ICH Q10
Zelmic has a GMP certification issued by the Swedish Medical Products Agency and a successfully implemented Quality management system compliant with EU-GMP for human and animal drugs. Our analytical service, including in vitro performance testing, is supported by GMP and CMC requirements of regulatory authorities worldwide.DOWNLOAD CERTIFICATE OF GMP COMPLIANCE
WHAT THIS MEANS FOR YOU
Our research and development team can support your development, manufacture, or transfer activities and is well acquainted with a GMP environment. In addition to the GMP requirement, our quality management system is compliant with ICH Q10. The versatility with both R&D and GMP system supports early and late-stage development characterization, formulation support analysis, stability testing, method development, and method validation through GMP batch release testing.
Chemical Engineer and MSc in Chemistry. David has more than 20 years of experience in research and development in Life Science. He has also been on the founding team of the women’s health company Pharmiva AB and has spent the last 5 years developing Pharmiva's first product against bacterial vaginosis. He is now the CEO and is one of the founders of Zelmic.
CO-FOUNDER, BOARD MEMBER,
Chemical engineer and entrepreneur with long experience of topical drug delivery and development of pharmaceutical products. Åke has founded several life science companies and is the inventor of more than 20 patented drug delivery technologies.
PhD in Chemistry and MSc in Nanoscience. Anna has several years of experience from topical drug research, transport of drugs in skin and mucous membranes, formulation stability and interaction of drugs with packaging materials.
HEAD OF QC AND DEVELOPMENT
Ph.D in Physical Chemistry. 20 years’ experience from managing research and development projects in the life science sector with companies such as Biogaia, Infant Bacterial Therapeutics AB and Astra Zeneca.
Susanna has a M SC in Chemical Engineering with more than 20 years experience in formulation development in pharmaceutical products. Extensive experience in formulation and process development working in companies as Astra Zeneca, Bioglan and Biogaia.