Regulatory Pharma Net, S.L. (RPN) is an international drug development
and regulatory affairs consultancy based in Barcelona and employs
30 professional
consultants.

RPN offers a full range of services related
to drug development plans, clinical and nonclinical strategy, paediatric clinical development,
international registration procedures, advanced therapy medicinal products,
eCTD/NeeS, as well as pharmacovigilance.

Challenge

Over the last few years RPN experienced
dramatic growth in the number of new clients
and projects. Today RPN has over
230 clients and oversees 200 active projects.
Many of these projects involve international
registration procedures. With
the main objectives of lowering the Timeto-
Market for a product and accelerating
the pace in each procedure, RPN faced a
large and growing amount of product and
registration data that needed to be stored
and maintained. In discussions with clients
with high numbers of planned or ongoing
procedures as well as marketed products,
RPN realized the need for a fast and easy
way to organize these large amounts of
activities and data. All relevant information
had to be available for everyone at any
time. Users had to be able to filter and extract
parts of the data without any difficulty,
and to be able to schedule and coordinate
the relevant activities during and after authorization
of a product.

Being familiar with all the various ways to
manage regulatory activities and data,
RPN already knew that the most important
aspect of a software solution would be an
easy–to-use product with an intuitive user
interface. A clear visualization of all procedures,
products, and respective related
activities was a clear must-have, as well
as a quick and effective search capability.
To realize the main benefit of such a
software solution – saving time and money
– RPN considered the key criteria for evaluating
a software solution to be its capabilities
regarding the scheduling of activities,
the visualization of project calendars, the generation of automatic alerts, as well
as the ability to generate detail and summary
reports.
After evaluating a number
of project
portfolio and registration management
solutions, RPN choose EXTEDO
DRAmanager.

Solution and results

RPN is utilizing DRAmanager to meet
two primary objectives: One is the internal
organization and synchronization of
all data from collaborations with different
clients, while the other is its direct
joint use with selected clients that require
optimized coordination of products
and procedures. The tenant-based design
of the software allows RPN to have
separate database sets for each client,
so that multiple collaborations are possible
without any issues.

RPN uses DRAmanager to reflect the current
state of the procedures and products
of a client as a basis to plan upcoming
maintenance activities, such as PSUR submissions,
variations, and renewals.
The synchronization and ease of control of
all regulatory data and associated activities
will reduce the time and cost spent during
product authorization and maintenance.
Additionally, the integration with other
software necessary for the preparation of
eCTDs and electronic reports of pharmacovigilance
will be a further step towards
global electronic regulatory affairs.

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