Our Story - who we are, what we do and how we can help you?
We are a team of consultants with over 17 year’s pharmaceutical industry experience as Specialists in regulatory, publishing, submission management and RIM/IDMP/EDMS systems.
We have helped companies with:
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CTA conversion from CTD to CTR through CTIS & MHRA’s portal
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eCTD product lifecycle by optimally maintaining via recycling, reusing and adapt submissions for global submissions
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Process Mapping, Scripting & Developing Learning Materials
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Submission format conversion and workflow optimisation
We worked as system admins for Veeva Vaults (RIM & PromoMats), EDMS systems (Veeva, MasterControl, Documentum, FirstDoc & CARA) and supported Data Visualisation tools like (QlikSense) for Reporting/Tracking to management.
We have developed and used authoring toolbars for eCTD compliant documentation (ISI Toolbox, Microsystems & StartingPoint Templates).
We have helped companies set up effiecient collaborative authoring, review and approval tools and workflows. We have helped many make the transition by using our in-house tools.
We have a strong R&D and science background, and we have also translated our regulatory, publishing, systems and cross-functional experience to help improve processes, document work-flows, translated guidelines into company standards.
Providing management extensive overview and tracking of regulatory processes using metrics and reports.
We can work laterally across functions giving us a unique perspective to optimize cross-functional work-flows.
Services
We have helped companies in 3 distinct areas through consulting, staff augmentation & CRO training & management. Click On the images or the section titles to find out more
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Converted several CTAs from CTD to CTR using CTIS. CTA submission through MHRA’s Portal
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Converted entire EU/US MAAs to ACTD/TH eCTD format, converted documents and retemplated CMC ASEAN secific documents
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Trained off-shore publishing teams (including training the trainer), writing and delivering eCTD training scripts to train CRO RegAffairs/publishers
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Helped clients successfully make the transition the entire product portfolio globally.
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Working on ROW Paper, NEES, hybrid & eCTD sequences using efficient reuse strategies based on US/EU/CH submissions.
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Worked on over 22 EU and US MAAs and also submission managed products for EMA, FDA, SWISSMEDIC, Canada Health, GCC, Jordan, South Africa, ASEAN and TGA.
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Submitted multiple parallel US/EU/CH major submissions. Experience in workshare eCTD submissions for over 20 products.
Some of the clients we have worked with
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Supported several Veeva vaults including RIM & PromoMats. Veeva certified system admin Global Regulatory Affairs and Regulatory Operations support with Regulatory Technology and Information Management.
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System & Process Validation and Quality Assurance.
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Business Admin and providing technical support of eCTDxpress, ISIpublisher, EDMS and System Admin for Advertising and Promotional PromoMats, Quality Docs, SharePoint 365 Migration and roll out of hug sites, modern and communication sites.
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Provided guidance to clients on mapping attributes in electronic document management systems
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Automated M5 dataset compilation and STF assignment for FDA submissions.
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Managed submissions, compilation, and publishing activities associated with generating simple and complex electronic submissions.
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Represented regulatory operations business needs to major IT projects such as choosing a new electronic document management system and publishing tools
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Implemented efficient collaborative writing and review tools for team based authoring, review and approval
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Writing, editing and QC of CSRs (M5) and summary documents (M2) for the successful submission and filing of a NDA submission with the FDA in the USA.
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Preparation of scientific advice, PIP and ODD applications for EMA and MHRA
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Writing and updating CSRs, Protocols and IBs in endocrinology, oncology and neurology.
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Preparation of summary documents, e.g. table of all studies, list of investigators and regulatory compliance (ICH E3).
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Performing quality control review of medical writing documents ensuring adherence to established regulations and client guidelines.
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Helped a company prepare for a FDA audit and MHRA inspection, answered FDA questions regarding the NDA application
Get in Touch
We work globally with consultants based in:
London
Basel
Brussels
email us: