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Paper-based regulatory dossiers are drawing to a close; regulatory dossiers in electronic format are a key business offering that will facilitate rapid review and approval in the global Bio-pharmaceutical marketplace.
The Aptuit Consulting Regulatory Team took a big step towards providing clients with a set of services allowing them to submit and manage US regulatory documents in eCTD (electronic common technical document) format. Our team recently provided a test submission to the FDA that was expeditiously accepted. The successful completion of this milestone now allows Aptuit Consulting to submit client reports to FDA in eCTD format.
Our Regulatory Submission Services are delivered by highly experienced publishing professionals who understand the regulatory requirements and are committed to completing projects on time.
Aptuit Consulting will be holding a free webinar to highlight this new service and will provide an overview of the eCTD regulatory requirements. If you would like to sign up or obtain more information please click here.
A Global Service
Aptuit is a drug development and pharmaceutical services company conducting research, development and manufacturing on a global contract basis for both large and small innovators.
Our mission is to engineer a better drug development process to provide solutions to our clients’ diverse and differing program needs.
Our complete suite of pharmaceutical services enables the client to realise their drug development program from proof of concept through to launch and delivery.
Aptuit INDiGO™ compresses these timelines still further delivering API to IND in just 26 weeks.
Click here to discover how our services can assist you.