Valuable information and company updates
Resources
Welcome to our library of news, media, knowledge sharing and product information.
Welcome to our library of news, media, knowledge sharing and product information.
ANDA
abbreviated new drug application
API
active pharmaceutical ingredient
ASMF
active substance master file
BLA
biologics license application
CAPA
corrective and preventive actions
CEP
certificate of suitability to the monographs of the European Pharmacopoeia
CMC
chemistry manufacturing and control
CMO
contract manufacturing organisation
CPO
contract pharma organisation
CQA
critical quality attributes
CTA
clinical trial application
DSUR
development safety update report
eCTD
electronic common technical document
EMA
European Medicines Agency
eQMS
electronic quality management system
FSMP
food for special medical purposes
FTE
full time equivalent
GDP
good distribution practice
GLP
good laboratory practice
GMP
good manufacturing practice
GVP
good pharmacovigilance practice
HEOR
health economic outcomes research
HTA
health technology assessment
ICH Q3D
international council for harmonisation of technical requirements for pharmaceuticals for human use guidelines for elemental impurities
ICER
incremental cost-effectiveness Ratio
IMPD
investigational medicinal product dossier
IND
investigational new drug
IVDR
in vitro diagnostics regulation
M&A
mergers and acquisitions
MAA
marketing authorisation application
MAH
marketing authorisation holder
NDA
new drug application
OOS
out of specification
OOT
out of trend
PBRER
periodic benefit-risk evaluation report
PIL
product information leaflet
PQR
product quality review
PSMF
pharmacovigilance system master file
PSUR
periodic safety update report
PV
pharmacovigilance
QMS
quality management system
QPPV
qualified person in pharmacovigilance
QA
quality assurance
QALY
quality adjusted life year
QC
quality control
QP
qualified person
R&D
research and development
RP
responsible person
SA
scientific advice
SMPA
Swedish Medicinal Products Agency
SmPC
summary of product characteristics
SOP
standard operating procedure
TPP
target product profile
WDA
wholesale distribution authorisation
Arex Advisor AB
Contact us
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
