The regulatory intelligence process at Soterius
includes identifying relevant regulatory information
from various sources and communicating the
information to the key stakeholders for analysis
with the overall intent of monitoring the existing and
changing regulatory landscape for opportunities
to create/modify processes and associated
documents. We can perform regulatory intelligence
activities for you to obtain information regarding
the current trends, regulatory updates, changes in
the guidance’s, etc. This is done through a review
of various regulatory websites, literature review, etc.
Product-specific regulatory/market intelligence can
also be built into the process, as required by you.
The
information obtained from such a search is assessed
for its impact on existing processes, organizational
strategy, training or other procedures. After a
thorough impact assessment, a decision may be
taken regarding action items, deliverables, and
timelines.
At Soterius, we have highly experienced SMEs who
can not only address queries across the GxP space
including safety and other operational requirements,
but also assist with framing regulatory strategy for
pre-approval or post-approval submissions be it
for biopharmaceuticals, combination products,
companion diagnostics, or gene therapy.
The personnel involved in the regulatory intelligence process typically have sufficient relevant experience and regulatory knowledge to be able to assess the impact of a new piece of information.
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