Pharma Regulatory

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



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 for NCES

Technology transfer

Formulation development

Pre-formulation services

Stability studies

Analytical development and validation