Regulatory
Services
The
regulatory experts at D-TARGET have over 20 years of
individual know-how in medical device, combination products
and tissue engineering products; offering you an unparalleled
source of strategic and tactical input for all your
projects. D-TARGET possesses the scientific background
and regulatory expertise neccessary in handling all
European and national requirements to successfully setup
and conduct your clinical studies - getting you through
the red tape fast and smooth. Our extensive global network
of contacts with Notified Bodies, Competent Authorities
and trade associations are your key to important savings
in time and money.
Development
of worldwide regulatory strategy and solutions to
practical needs concerning:
•
CE mark process
•
conformity
assessment
•
notified
body selection and ongoing contacts
•
development
of risk assessments
•
strategy
development
•
pre-clinical
strategy development
•
preparation
of expert assessment
•
liason
with Notified Bodies and Competent Authorities
•
Combination Products
•
classification
and strategy
•
data
requirements
•
authority
contacts
•
Biological Products
•
advanced
therapy medicinal products
•
non
viable human tissue products
•
animal
tissue products
•
marketing/national
strategies and advice
•
preparation
of submissions
For further information on D-TARGET regulatory services,
please contact
us.
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