Intelligent eSubmissions
Using intelligent tools, automation & processes to help you manage high quality regulatory submissions with Health Authorities globally
Regulatory Operations, Processes & Systems
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MAA eCTD Lifecycle
Managed routine and complex submissions, interacting cross functionally providing publishing support across multiple products. Published EU, CH, AU, GCC, CA and US eCTD sequences. eCTD Product Life-cycle management including compiling, assembling, publishing, dispatching, archiving and tracking regulatory submissions while ensuring compliance and validity for paper, NeES and eCTD.
CTA
Strong CTA (CTR/CTIS), Scientific Advice, ODD, PIP Document Formatting and publishing experience and helped affiliates create a process to build and customise hybrid submissions.
Document Processing
Document processing while formatting 1000’s of documents this includes keyword linking and bookmarking using ISI and Adobe tools. Document processing (Scan, OCR, scale, bookmark/hyperlinking and auditing)
Redaction & Clinical Disclosure
Preparing products for Clinical Disclosure Policy 0070 Submissions to the EMACreated Redaction company guidance and working instructions for Policy 0070 and to supporting new CTA requirements