eCTD NeeS XML dossier publishing

eCTD NeeS XML publishing

eCTD NeeS

We offer you professional dossier preparation and publishing in eCTD and NeeS format together with consultancy on country specific requirements often resulting from additional national regulations. Thanks to our regulatory experience and complementary services for medicinal products we provide comprehensive support for Client's projects.

We are the official partner and distributor to Chan Tengri - software provider and to Balajka M+A, s.r.o. - main software distributor and consultant, responsible for technical support for EU clients of Chan Tengri, which provides eCTD and application management solutions for Slovak Agency (SUKL). We offer range of proven software from affordable eCTD publishing tools for particular projects without need of a server (eCTD tool) to comprehensive dossier and application management systems, business intelligence systems, medical representative management systems and other solutions successfully used by the companies. Unique scalable and flexible character of offered solutions allows to adjust software to particular Client's needs and utilise current IT infrastructure in the company to lower costs of implementation.

Our offer of eCTD and NeeS (non eCTD electronic submission) services:

► consultancy on country specific requirements and choosing solution best suited for Client's project and future plans

► preparation of regulatory dossier (see Consulting) and publishing in eCTD or NeeS (non eCTD electronic submission) format

► reformatting current dossier into eCTD or NeeS

► consultancy and long term eCTD solutions including eCTD dossier management after marketing authorization (variations, renewals etc.)

► comprehensive regulatory affairs services for the projects (see Medicinal products).

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