Regulatory & Compliance.
Navigate registration, licensing and lifecycle requirements with each national authority.
Discuss regulatory & complianceExpertise that moves
your next step forward.
Navigate registration, licensing and lifecycle requirements with each national authority.
CTD dossier preparation
Review available product documentation, identify dossier gaps and organise the Common Technical Document for the target market.
Local agent / MAH representation
Coordinate local representation and clarify responsibilities between the manufacturer, local agent and marketing authorisation holder.
Registrations & renewals
Support submission planning, authority queries and renewals to keep the registration pathway organised.
Variations
Help manage product changes after approval, with documentation and coordination appropriate to the agreed regulatory scope.
Import permits & product licensing
Coordinate product licensing and import-permit requirements with the wider market-entry and supply plan.
For manufacturers preparing a first submission, addressing documentation gaps or managing the lifecycle of an already registered product.
A regulatory roadmap covering the proposed route, dossier gaps, responsibilities and milestones. Authority decisions and timelines remain outside our control.
One partner across
access, registration,
launch and supply.
One partner across access, registration, launch and supply, so nothing gets lost between handovers.
Explore our approach