Have you ever caught yourself thinking that the digitalization goes too quickly? Have you realized that you need to use specific and multiple gateways to transfer your regulatory files to agencies and you struggle with that? Have you found out that you need to complete a lot of administrative steps prior to submitting your files to regulatory agencies? Have your experienced that Module 1 documents of the regulatory submission take a lot of your time?
This is the time you meet our Operations team, who can help you with all these and many more activities you would like to avoid spending your valuable time on.
Our Operations team has prepared multiple eCTD submissions, converted thousands of documents to eCTD compliant format, prepared hundreds of Module 1 documents, ensured multiple translations of product texts, created thousands of entries in Regulatory information management systems, helped multiple clients with CESP, CTIS, OMS, IRIS, ESG and many others systems and gateways.
If you are struggling with any of these activities, allow us helping you. We look forward to hearing from you via our Contact form.
