REGULATORY AFFAIRS SERVICES

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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 regulatory strategy
		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