Address: 1 Broadway, Cambridge, MA02142 (America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
Date: Saturday, June 3rd, 2023
Location: Boston Marriott Cambridge
Date: June 5-8, 2023
Location: Boston, MA
Booth: 2275-J
As of Beijing time The data is from a third-party organization and is only for reference.
For actual information, please refer to:www.eastmoney.com
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Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(U.S. - West Coast)
0044 7790 816 954 (Europe)
China:
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
1) Development of analytical method (starting materials, intermediates, API, Middle controlled Analysis, preliminary degradation tests)
2) Validation of analytical method (use pilot batch samples, if no pilot batch, use safety assessment batch)
3) Stability study (pilot batch or safety assessment batch + GMP batch)
• Influence factor study (in early stage, use Laboratory scale for pre-influencing factor test)
• Accelerated stability study (6 months)
• Long-term stability study (24 months or extended to 36 months)
4) Preparation and writing of declaration documents in CTD format