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For actual information, please refer to:www.eastmoney.com
Address: 20 Maguire Road, Suite 103, Lexington, MA 02421(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
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Business Inquiry
Global:
Email:marketing@medicilon.com
+1(626)986-9880(U.S.)
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 (using pilot batch samples, if no pilot batch, use safety assessment batch)
3) Stability study (using pilot batch or safety assessment batch + GMP batch)
• Study of influencing factors (early stage testing using laboratory scale)
• 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