Read more – here is a detailed description of our areas of expertise. Click here to download PDF files. • Services Overview • Preformulation and formulation services • Clinical Trial Material manufacturing and packaging • Analytical services • QC testing • Stability services • Regulatory services • Project Management Galenica specializes in drug development support for the pharmaceutical industry. We are experts in formulations, analytical development/validation and production of Clinical Trial Material (CTM) for Phase I - III. Supporting pharmaceutical development in all phases from choice of candidate drug to finished product. We are GMP compliant for production of clinical trial material of the most common dosage forms. Our analytical team uses a variety of analytical techniques for pharmaceutical development, release of produced CTM and monitoring of stability studies. Galenica is authorized and audited by the Swedish Medical Product Agency for GMP production of CTM. We welcome you to visit our facility for audits or to discuss your project needs. Summary of services • Feasibility studies and desk-top evaluations • Preformulation on a small scale physico-chemical data compilation to compatibility and stability studies • Analytical development to validation and QC release testing • Preclinical formulations intended for GLP studies. • Formulation development of all common dosage forms. • Production of CTM, covering clinical phases I to III in our state of the art GMP suites • Stability studies according to ICH • Regulatory services, from IMPD to full Module 3 compilation • Product scale-up and process validation at production site of partner’s choice