We have the professional formulation technical platform and the most experienced team, which could offer fully integrated pharmaceutical services and meet different requirements of our clients. We focus on the development of solid dosage forms, semisolid dosage forms, liquid dosage forms and sterile dosage forms. Our formulation group is also highly experienced in developing sustained release dosage forms, micro-particle dosage forms, protein and peptide drugs, etc. We have a good track record of successful integrated drug development programs for our clients. We can apply to FDA, CFDA and EMEA.
With a very small quantity of active pharmaceutical ingredients (API) or druggable candidate molecules, Medicilon’s pre-formulation service can provide valuable information and expertise to guide the compounds to next steps. Our pre-formulation team has extensive experience on handling a wide range of compounds and we can suggest the path forward for early success.
Medicilon provides full range of analytical services, including method development and validation, analytical testing and release, stability study, large scale separation and regulatory CMC documentation services. State-of-the-art instruments, cutting-edge technologies and experienced scientific staff ensure efficient, high-quality and cost-effective services.
Different dosage forms and manufacturing process may face different situations and problems in product development. A proper formulation and process should be employed to make sure the formulation and the scaled up process are reasonable and dependable and all the in process steps could be controlled effectively.
Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control. Our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and CFDA guidelines.