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