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Regulatory
affairs and clinical
research outsourcing offers
a number of advantages
to pharmaceutical companies. This way a marketing authorisation holder or sponsor can convert the fixed costs of maintaining
the personnel, expertise
and facilities necessary
for regulatory approval processes
and clinical trial
management into variable
costs. The Polish
company Farchim-Pol
offers full
service in these fields
including:
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Preparation, submission and care of
marketing authorisation applications
for medicinal products being
registered in national
or European procedures (DCP and MRP)
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Review of SPC, PIL
and Labelling documents
for the Centralised Procedure
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Preparation of dossiers in the CTD format
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Preparation of dossiers in the eCTD
format (as the first company
in Poland)
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Reformatting old NTA dossiers to the
CTD/eCTD format
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Ordering stability tests in reputable Polish
laboratories
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Pharmacovigilance service for
international marketing authorisation
holders having no
local safety unit
which is mandatory according to
the Polish law
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Organisation of phase 3 clinical trials in Poland, choosing
the right sites, patient monitoring and all
regulatory work to support
clinical trial applications in Poland.
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Organisation of inexpensive bioavailability
and bioequivalence studies
in Poland to support applications
for registration of generics
in the European Union.
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Preparation, submission and monitoring of marketing authorisation and renewal
applications for medical
devices (CE certification) and biocidal products
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Organisation of product manufacturing
in Poland
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If needed, Farchim-Pol
can act as Marketing
Authorisation Holder
in Poland and in other countires.
We have been active on the Polish
market since 1996. Our
clients (i.e. Pfizer,
Genzyme (now Sanofi-Aventis), Abbott, Aspen Pharma, Fresenius Kabi, Hospira, SmithKline Beecham, Coloplast, Dr.
Klein, Thor, Torrex Pharma Bio-Diät and numerous Polish companies) rely upon our expertise and experience.
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