Services

AREMA provides tailored technical and regulatory advice, strategic studies, guidance and full regulatory assistance according products and concerned countries to introduce. These consulting services are offered by AREMA either on an annual subscription, according number of hours of intervention or on a specific request basis. Services are provided in the following areas:
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Regulatory studies

We provide you full report on country regulatory p...
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Regulatory intelligence

Our regula...
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Dossier evaluation

Audit and evaluation of the dossiers of the medeci...
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CTD dossier

Preparation of the CTD registration dossier, we co...
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Submission and registration

After appropriate evaluation and /or preparation y...
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Expert overviews

Preparation and signature of expert overviews (mod...
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Labelling

Labelling including: leaflet, SPC, inner/outer lab...
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Clinical studies

We offer various services according local regulati...
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Pharmacovigilance

We offer Pharmacovigilance and materio...
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Trainings

We can provide customized onsite training upon req...
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Market studies

We provide adequate Market and pricing studies for...
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eCTD

AREMA provide eCTD software services and woul...
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Maintenance and life cycle Management

We ensure maintenance and regulatory complianc...
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