Muridda undertakes Phase I and Phase II clinical trials. From Phase I clinical studies to final registration and submission, we help innovative and breakthrough pharmaceutical products launch to the market as soon as possible and benefit patients through our strict quality control system and the extensive experience of our professional team.
Clinical Registration and Submission Services
- Preparation and submission of regulatory dossiers. Review, organization and technical evaluation of IND/ANDA submission documents provided by clients; further drafting, reviewing, editing and finalization of dossiers.
- Prior to submission: detailed analysis of the submission project.
- After submission: a senior submission specialist will maintain continuous communication with regulatory authorities, follow up on the progress in real time until the successful completion of the application.
- Project Management Services
Clinical Service Items
- Early Clinical Services
- Clinical Operations Services
- Clinical Data Management and Statistical Analysis
- Medical Affairs
- Regulatory Affairs
- Quality System Management and Consultancy
- Single-country Phase II Clinical Bioanalysis
- Drug Distribution Studies
- Immunotoxicity and Immunogenicity of Biologics
- Volunteer Subjects