Regulatory Affairs

Inpharmatis offers comprehensive Regulatory Affairs, Drug Development and Vigilance services to pharmaceutical, medical device, cosmetic and biotech companies.

Our area of expertise lies in European market, however though our network of credible partners we are able to manage also CIS, US, Latin America and selected RoW procedures.

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Pharmacovigilance

Audited EU Pharmacovigilance System, QPPV Services, PSMF, PSURs, RMP development, Development and implementation of Quality System, Audits, eSubmissions and training.

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e-Submissions

Official Extedo Representative of Extedo GmbH: leader in eSubmission software development for RA and PhV.

– Used by more than 70% of Health Authorities in the world

– Preparation of eSubmissions for Clients in eCTD and other formats

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GMP/GDP Auditing

– Development of Quality documentation

– GAP analysis and GMP auditing

– GAP analysis and GDP auditing

– Training

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In-house training

Would you like one of our training courses delivered at a time and location to suit you? Would you like us to develop a course to meet your Team’s requirements? Address your Team’s specific needs with a tailored training approach!

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Scientific and Medical Writing Services

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