Document Migration

PRODUCTS

  • Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).

  • Several of our recent Life Sciences podcasts have featured conversations about the rapid shifts taking place in this dynamic industry. Automation and information management technology are rapidly advancing to help address these challenges.

  • Altasciences’ experienced team specializes in early-phase renal and hepatic impairment studies, delivering tailored clinical pharmacology trials that support your regulatory submissions.

  • Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.

  • From product development to translation into clinical trials, GTx’s clinically validated scalable electroporation technology is equipped to handle your most complex cellular engineering demands.

    • Rapidly transfect from 75 thousand to 20 billion cells
    • Move forward with 21 CFR Part 11 enabled software
    • Develop quickly with an established regulatory path supported by a FDA Master File
    • Manufacture confidently with closed, cGMP-compliant, ISO-certified and CE-marked products
    • Enjoy MaxCyte’s proprietary Flow Electroporation® technology

WHITE PAPERS AND CASE STUDIES

NEWS