Services

Pharma Regulatory
Consultancy

Regulatory strategy


CMC & manufacturing compliance


Market authorization application in EU


Product life cycle management


Dossier publishing

Medical Writing

Preclinical study reports


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


Clinical protocols


Investigator brochures


Investigational Medicinal Product Dossier (IMPD)


Informed Consent Forms


Writing and compilation of CTD modules


PSURs


Narratives


Clinical and non-clinical Expert reports


Clinical and non-clinical overviews


Extensive literature search for Module 4 and 5


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


Scientific and protocol advice

Research and
Development

Development for NCES


Technology transfer


Formulation development


Pre-formulation services


Stability studies


Analytical development and validation