Personal Information
Organization / Workplace
Waalwijk, Noord-Brabant Netherlands
Industry
Medical / Health Care / Pharmaceuticals
Website
About
eCTDconsultancy advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/ strategic and operational aspects of drug development. We apply a scientific approach to working with Regulatory Submissions that ensures the highest possible quality of Regulatory Dossiers, with an ultimate aim of providing benefits to applicant, agency and patient.
Tags
ectd
esubmission
ectdconsultancy
ema
regulatory operations
dmf in ectd
ro
ec12342008
grouping
regulatory affairs
worksharing
electronic submission
adverse drug reactions
xevmpd
eudravigilance
common technical document
mah
qdossier
compliant submissions
emea
registration
ra
new variation regulation
variations
easmf
common european submission portal
cessp
brexit
ectd baseline
gdpr
electronic drug master file
active substance master file
asmf
drug master file
dmf
entitity extraction
text mining
linked data
idmp
identification of medicinal products
structured authoring
electronic submissions
baseline
reformat
xevprm
psur
pharmacovigilance
var type
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