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FDA Consulting Group.

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ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
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API – Active pharmaceutical ingredient
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ASMF – Active Substance Master File
ATMPs – Advanced therapy medicinal products
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BLA - Biologic License Application
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C&P – Chemistry and Pharmacy
CA – Competent authority
CANDA – Computer assisted new drug application
CAP – Centrally authorized product
CAPA – Corrective action and preventive action
CAPLA – Computer Assisted Product License Application
CCDS – Company core data sheet
CD – Controlled drug
CDSCO – Central Drug Standard Organization (India)
cGLP – Current good laboratory practice
cGMP – Current good manufacturing practice
Cl – Total body clearance
CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
CMP – Certificate of Medicinal Product
COA – Certificate of analysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
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CPP – Certificate of pharmaceutical product
CQA – Clinical quality assurance
CR – Controlled release
CRO – Clinical Research Organization
CSI – Core safety information
CSP – Core safety profile
CSR – Clinical study report (European Union)
CT – Clinical trial
CTA – Clinical trial application
CTA – Clinical trial authorization
CTD – Clinical Trials Directive
CTD – Common technical document/dossier
CTMS – Clinical trial management system
CTS – Common technical specification
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