Submissions Services
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Services of other enterprises
Description
We offer services for the preparation of following regulatory submissions:
- USFDA, USP - DMF, NDA, ANDA, AANDA
- EDQM - COS
- EDMF
- Product dossiers - EU & other countries, MHRA, MCC, TGA
- Site master file
- Quality manual - ISO 9001:2008
- Reply to DMF deficiencies
- Providing additional/supplementary information
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Submissions Services
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