Strategic Support, Start to Post-Marketing.
VIGIVANCE provides strategic regulatory guidance across the full product lifecycle, helping sponsors navigate diverse regulatory environments with confidence.
End-to-end regulatory support across product development, registration, market access, lifecycle management and post-approval compliance across diverse regulatory environments.
8 Regulatory Capability Areas
Eight core areas, coordinated under one accountable team, from early strategy through post-marketing compliance.
Regulatory strategy is shaped around your product and target markets from the outset, so the development path stays efficient and predictable.
CTD/eCTD dossiers are prepared, reviewed and published to a consistent standard, with lifecycle tracking maintained through every update.
Registration and marketing authorisation support spans new products, generics and established brands across national and regional procedures.
We manage the day-to-day exchange with health authorities, from deficiency responses to meeting preparation, so queries are answered on time.
Variations, renewals and post-approval changes are assessed for regulatory impact and managed through to approval across your product's lifecycle.
SmPC, package leaflet and labelling content are kept aligned with current safety information and reviewed for regulatory accuracy at every update.
Regular compliance and GAP assessment, backed by structured CAPA and remediation, keeps regulatory documentation inspection-ready.
Ongoing monitoring of regulatory and legislative change is translated into practical impact assessments, keeping registrations current market by market.
We prepare and publish CTD/eCTD dossiers to a consistent standard, with administrative documentation and lifecycle tracking maintained through every subsequent update.
Submission compilation is handled with close attention to each health authority's specific format and procedural requirements, reducing the risk of avoidable deficiency queries.
Our team manages the day-to-day exchange with health authorities, from deficiency responses to meeting preparation, so queries are answered accurately and on time.
We track every variation, renewal and post-approval change for regulatory impact, keeping registrations current across every market you operate in.
Regulatory Strategy to Post-Marketing, Fully Aligned
Core regulatory capability areas, coordinated under one accountable team.
Share a few details below and our team will connect you with the right expertise for your requirement.