When time is pressured you need fast thinking on how best to proceed for clients and patients. We quickly negotiated with authorities and established a regulatory submission strategy, complete with critical milestones. Once this was ready, samples of the marketed product were submitted to the health authority.
During the assessment of the marketing authorization renewals, we also advised our client on supply initiatives to ensure that enough stock remained available to patients.
In parallel, we sourced the missing Normative Document from the local authority and ensured the dossier was updated in line with all the regulatory strategy milestones.
We assisted the client with a complete list of renewal requirements (Regulatory Intelligence support) and evaluated the client dossier against industry requirements with the help of our local partner, who checked the dossier against national requirements to ensure full local compliance. We knew a dossier gap analysis would identify and correct gaps in time to complete a full dossier update.