- 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. |
