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Services

Drug Registration

5

Drug Registration under EAEU Rules

Registration by Mutual Recognition Procedure

Amendments

Maximum Selling Price Registration

Pharmaceutical Substances Registration

Registration Dossier Development

5

Dossier Expert Review

Quality Control Document Development

SmPC and Package Leaflet Development

Quality, Preclinical and Clinical Documentation Development

eCTD Dossier Preparation

Research & Development

4

Pharmaceutical Research & Development

Preclinical & Clinical Studies

package-leaflet-user-testing

Independent Drug Quality Control

Pharmaceutical Outsourcing

3

Regulatory Affairs Department Services

Pharmaceutical Substances Sourcing & Supply

Project Management for Development, Technology Transfer, Localization & Contract Manufacturing