ectd leaflet euphar
TRANSCRIPT
8/14/2019 eCTD Leaflet Euphar
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Regulatory Affairs Readability User Testing Comparison of SmPC for MRP European regulatory strategy Labelling and Mock up Marketing and Authorisation Applications – Decentralised
and MRP as CMS or RMS, National procedure Post-marketing activities – product maintenance – renewal,
variation Preparation of Module I according to the local requirements Preparation of Module II Reformatting the paper CTD dossier to the new eCTD
Pricing and reimbursement strategy Pricing assessment Public policy assessment Reimbursement negotiation strategy
Our software to your success
Headquarter: Office: Contact:
Euphar s.r.o. Euphar s.r.o. www.euphar.czZlíchovská 193/5 Ke Schodům 1397/20 mobile: +420 731 16 99 14143 00, Prague 4 143 00, Prague 4 tel./fax: +420 241 40 31 73Czech Republic Czech Republic email: [email protected]
We are ready offer to you with any other services:
eCTD Prima® is a software product for the creation, viewing,manipulation and archiving of regulatory dossier by pharmaceuticalcompanies to the regulatory authorities.
eCTD Prima® has everything what you need to satisfy requirementsfor submission to multi-region agencies.
Only 1-3 days training – easy to understand and to start workingimmediately.
Do you need to submit your dossier
in eCTD format on time?
Then you need eCTD Prima® software!
E a s y
a n d q
u i c k
w o r k w i
t h s o f
t w a r e
e C T D P r i m
a ®
eCTD Prima® is attacking chaos
complexity of documents
inefficiencies
Pro e 2 26.9.2008 10:08 S rán a 1
8/14/2019 eCTD Leaflet Euphar
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T h e m a i n f u n c t i o n o f t h e e C T
D P r i m a
® i s
t h e c r e a t i o n o f t h e d o c u m e n t a t i o n i n e C T D f o r m a t .
W e s y n t h e s i s e d I T b a c k g r o u n
d a n d R A k n o w l e d g e b y d e v e l o p i n g t h e s o
f t w a r e e C T D .
T h e m a i n t a s k s o f t h e p r o g r a m
d e v e l o p m e n t w e r e :
e a s y n a v i g a t i o n a n d c l e a r
s t r u c t u r e ( m a i n l y f o r M R P / D C P p r o c e d u r e
s )
s m o o t h f u n c t i o n i n g w i t h i n t u i t i v e a n d f r i e n d l y u s e i n t e r f a c e .
e C T D
P r i m a ® w
a s d e v e l o p e d b a s e d o n I C H a n d
E M E A r e q u i r e m e n t s a n
d f u l f i l s c r i t e r i a f o r x m l
s u b m i s s i o n b u t t h e d e s i g
n a n d f e a t u r e s w e r e b u i l t
o n t h e R e g u l a t o r y A f f a i r s k n o w l e d g e a n d 1 1 - y e a r
e x p e r i e n c e w i t h s u b m i s s i o n o f r e g i s t r a t i o n .
T h i s i s
t h e r e a s o n w h y o u r s o f t w a r e i s c l e a r a n d e a s y t o
n a v i g a t e .
T h e b e n e f i t s e C T D P r i m a ® :
i m p r o v e d d o s s i e r q u a l i t y ,
f a s t a c c e s s t o d o s s i e r f o r e v e
r y o n e w h o h a s a c c e s s t o e l e c t r o n i c d o s s i e r ,
l e s s p a p e r q u a n t i t y ,
g o o d p r i c e f o r s o f t w a r e
c o s t e f f e c t i v e n e s s ,
n o l i m i t a t i o n o f a c c e s s t o s o f t w a r e i n c o m p a n y ( o n l y c o m p a n y p o l i c y c
a n l i m i t a c c e s s ) .
e C T D P r i m a ® i s
b u i l t o n e C T D a r c h i t e c t u r e f o r a l l t y p e s o f r e g i s t r a t i o n
p r o c e s s e s : C P , M R P , D C P a n d
N P
A s
k f o
r t h
e b
e s t
s o
l u t i o
n
u s e
e C T D
P r i
m a ®
O n l i n e a c c e s s a n y t i m e
e C T D P r i m a ® e
l i m i n a t e s I T a n d R
A h e a d a c h e , e r r o r - p r o n e
p r o c e s s e s t h a t t r a d i t i o n a l l y h i n d e
r p r o g r a m u s i n g ( n a m i n g
o f f i l e s i s i n d e f a u l t p a t h s ) .
e s s ) .
e C T D P r i m a ® a
l l o w s y o u
t o c o m p i l e a
d o s s i e
r s t e p
b y s t e p w i t h l o g i c a l
a n d i n t u i t i v e
n a v i g a t
i o n
e C T D P r i m a ® o
r g a n i s e d
a t o t a l m e s s i n n a m i n g
a n d s t r u c t u r e o f f i l
e s
Y o u w i l l k n o w w h o
a n d w h e n f i l e s
w e r e c h a n g e d .
Pro e 2 26.9.2008 10:08 S rán a 2