- Mutual Recognition Procedure (MRP)
- Decentralised Procedure (DCP)
- National Procedure
- Dossier harmonization with European acquis
- Applications: Well Established Use, Generics & others
- Expert Reports
- Translations
- Variations
- Registration of Clinical Trials
MRP, DCP, National Procedure, Applications:
Generic and Well Established Use, Harmonization
of dossier with European acquis
Using our service you can submit your dossier and
you will be informed, day by day, of our activity
in the Agency and about actual status of your dossier.
Our experience is huge: we have participated in number
of MRP submission from the very beginning. Since
DCP is a "special MRP" our experience with
MRP should be also helpful in DCP.
Expert Summaries (Reports, Overviews)
We have prepared number of reports, overviews,
summaries (depending on the kind of dossier) written
for different purposes. With the exception of chemical
report we will prepare for you: pharmacological,
toxicological and clinical reports, overviews, summaries based
on the up-to-date data and literature. Both for new
medicinal products and for generics. In the letter
case: pharmacology and toxicology will cover the
active substance and impurities, clinical report
will address critically bioequivalence studies (see
Bioequivalence).
For CTD format we will write for you all necessary
overviews, summaries, nonclinical and clinical study
reports.
Translations
In the course of preparation of documents many
translations are necessary. We will take care of
all of them. We have translated all materials necessary
for MRP, DCP and national submission. These include:
Summary of Product Characteristics, Patients Information
Leaflets, in addition to all other documents required
by the Agency. Our experience is long as we are in
translation for many years so whether it was easy
or difficult we know all the peculiarities of the
appropriate section in the Agency.
Variations
In the past we have participated in many various
procedures so we have the experience with all kind
of variations. Our experts formerly worked for
the Agency so our knowledge about variations
is complete and we will assist you in filling of
any kind of variation.
Registration of clinical trials
Here our experience is enormous. In the past we
were filing many requests for registration
of clinical trials in section "Cebek" of the Agency.
In case you plan to submit registration
of clinical trial we strongly suggest to contact us before
such submission. Our help may speed up such registration
and help you to negotiate the best conditions.
Our service include: application for
registration of medicinal products, monitoring of
registration process, direct contact with
Drug Registration Agency, all kinds of experts
reports or overviews, help with MRP, DCP,
National Procedure and WEU including translations,
Rx or OTC switch, and use of Biopharmaceutical
Classification System in generic applications.
Our experience: 34 MRP procedures finalized, numerous
expert reports & overviews mostly pharmaceutical
and clinical, numerous successful variations, numerous
translations and handling: Summary of Product Characteristics
and Patient Leaflets. |
