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Jouhou Koukai - Japan market access | regulatory & pharmaceutical affairs

Consultants and consulting for regulatory affairs, auditing and training in the pharmaceuticals, biopharmaceuticals, medical devices, in-vitro diagnostics, biologicals, food, beverages, dietary supplements, nutraceuticals, cosmetics, veterinary medicine, healthcare, clinical trials, research, contract and outsoutcing, and life sciences industries
Categories: Business, Health and Wellness
Topics: active pharmaceutical ingredient, approval, approval review, authority, authorization, biologicals, biologics, digital signatures, e-signature solution, japan market access, japan market access drug approval, jouhou koukai, pharmaceutical affairs, regulatory, regulatory &

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ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
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CAPLA – Computer Assisted Product License Application
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CD – Controlled drug
CDSCO – Central Drug Standard Organization (India)
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CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
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COA – Certificate of analysis
CoFS – Certificate of Free Sale
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CP – Comparability protocol (USA)
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