Inpharmatis offers
comprehensive consultancy regulatory affairs services
for pharmaceutical, biotech and medical device companies in Europe, CIS, EAEU and other countries.

Inpharmatis provides full range of regulatory affairs consulting services for registration of medicines, medical devices, dietary supplements, cosmetics across Europe, CIS, EAEU: Uzbekistan, Kazakhstan, Russia, Belarus, Kyrgyzstan, Moldova, Armenia, Georgia, Tajikistan, Turkmenistan, Ukraine, Azerbaijan, Mongolia, Latvia, and others. 

Inpharmatis covers all region countries with local, highly qualified, experienced, multilingual regulatory affairs specialists.

Inpharmatis provides full regulatory support over the whole life cycle of your product.                                                                

Inpharmatis Regulatory Affairs Services:
Project management of all regulatory submissions 
Comprehensive regulatory consulting 
Development of regulatorystrategy 
GAP analysis of dossier
Preparation of a regulatory plan and a list of required documents  
Preparation of regulatory documents for submission 
Regulatory support  
Preparation of dossiers for registration of pharmaceutical products as per the requirements of EAEU, CIS, EU 
Bringing the registration dossier with the EAEU requirements 
Update the documentation for registered medicinal products  
Development of product information leaflets (PIL) and / or summary of product characteristics (SmPC) in accordance with national or EAEU requirements
Conducting readability user testing of patient information leaflets (PIL RUT)
Full dossier development, including development of separate modules of the common technical document (CTD)  
eCTD Publishing  
Approval and review of advertising materials for medicinal products with regulatory authorities  
Medical writing and high-quality translation of documents needed for submission 
Regulatory Intelligence 
We guarantee highly qualified support, deadline compliance, and project control!