Services

Regulatory strategy

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CMC & manufacturing compliance

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Market authorization application in EU

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Product life cycle management

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Dossier publishing

Preclinical study reports

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Clinical study reports (Phases I to IV) compliant with ICH E3 standards

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Clinical protocols

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Investigator brochures

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Investigational Medicinal Product Dossier (IMPD)

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Informed Consent Forms

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Writing and compilation of CTD modules

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PSURs

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Narratives

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Clinical and non-clinical Expert reports

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Clinical and non-clinical overviews

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Extensive literature search for Module 4 and 5

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Preparation of summary of product characteristics (SmPC), patient information leaflet (PIL) in QRD format

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Scientific and protocol advice

Development for NCES

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Technology transfer

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Formulation development

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Pre-formulation services

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Stability studies

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Analytical development and validation

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