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2from Limited: Services

2from Ltd has extensive experience in all aspects of drug safety, providing customised strategic and scientific solutions focused on Pharmacovigilance and clinical risk management, to move your produce from development to commercialisation.

Categories: Health
Topics: 2from limited, adr reporting, adverse event software, clinical risk management, drug safety software, pharmaceutical risk management, pharmacovigilance, pharmacovigilance system, safety database

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HOME
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Sucuri WebSite Firewall - Access Denied

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ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
AE – Adverse event
AIM – Active ingredient manufacturer
AIMD – Active implantable medical device
ANDA – Abbreviated new drug application
API – Active pharmaceutical ingredient
AR – Assessment Report (European Union)
ASMF – Active Substance Master File
ATMPs – Advanced therapy medicinal products
BA – Bioavailability
BAP – Biotechnology Action Program
BIND – Biological investigational new drug
BLA - Biologic License Application
BWP – Biotech Working Party (EMA)
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)
CP – Comparability protocol (USA)
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
CVM – Center for Veterinary Medicine (US)
DACS – Detailed and critical summary
DAE – Discontinuation due to an a

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