Submission Management
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Early Phase
We can help with preparing/compiling CTA documentation and provide support converting CTD to CTR for submissions through CTIS, Swissmedic or MHRA’s portal. For FDA CBER and CDER we can now
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Develops regulatory strategic options to support business decision making and help optimise the workflows for regulatory filings.
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Preparation of routine to complex regulatory submissions..
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Co-ordinate submissions in line with ICH requirements, regional requirements and company procedures.
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Preparing and co-ordinating regulatory documentation to support early phase development including Scientific Advice, PIP, ODD and Clinical Trial Applications/amendments
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lead regulatory activities ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI).
MAA and eCTD life-cycle product Management
Preparation of eCTD sequences for Variations, line-extensions, renewals..using client companies procedures, tools and workflows
We have also built eCTD sequences in-house for regulatory filing and submission to FDA, EMA, MHRA, Swissmedic and TGA