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Pharmaceutical Dossier Services
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Pharma Dossier Compiling / Writing
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Pharmaceutical dossier is highly detailed and exhaustive document on the drugs which
requires extensive datas on its various aspects. Dossier compilation requires skills
of sourcing, interpreting and writing this document. This process of pharma dossier
compilation needs a talented team of pharmacists, data analysts and research assistants.
The entire procedure is highly time consuming and costly. For this pharma dossier
compilation and writing please feel free to contact us.
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Herbal Dossier Compiling / Writing
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Herbal drugs are getting higher acceptance as an alternative medicine. Therefore
some countries have started the registration for herbal drugs as well. Recently
we are working on compiling and writing herbal dossiers too.
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Pharma CTD / ACTD Dossier
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Drug regulatory affairs in pharma industries has mandated two types of dossier namely
CTD ( Common Technical Dossier) and ACTD ( Asian Common Technical Dossier ). Regulated
pharma markets (eg.USA, Europe ) markets require submission of dossier in CTD format
which has to provide clinical trial and bioequivalence studies. As against this,
semi-regulated pharma markets (South East Asian and Gulf Countries) require ACTD
format which does not require exhaustive details like CTD.
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Pharma Dossier Validation
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For successful registration of medicines pharma dossiers validation is very vital.
Several countries require some additional and specific drug information which needs
to be incorporated in the standardize CTD and ACTD format. So verifying and assuring
this match between the specific information required and the dossier prepared is
known as pharma dossier validation. This is where we offer you our expert services
at an affordable cost.
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Pharma Regulatory & Registration Procedures
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Being a highly regulated industry, pharmaceutical regulatory affairs have become
very pivotal for all the companies. Pharmaceutical consulting for the registration
procedures is indispensable and expensive. For these regulatory affairs pharmaceutical
dossiers are key factors wherein we offer our pharma consulting services.
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Registration of Medicines
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Due to enormous number of medicines available worldwide, countries have enforce
registration procedures for regulating quality. Company registration process is
a preceding step for the registration process of medicines. With our contacts we
can facilitate both company registration and registration of medicine.
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Country List
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ICPC provides pharmaceutical dossiers for almost all the countries of world.
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