MEDICINES / MARKETING AUTHORISATION & MAH
Find a medicine dossier to license. Assess the rights, evidence and route to implementation in each selected CEE market.
A country-by-country programme for selected CEE markets, with Poland as an agreed starting point where appropriate. EU/EEA and non-EU pathways are assessed separately.
You are a pharmaceutical company, portfolio owner or commercial partner seeking a medicine in-licensing opportunity or planning to extend an existing product into CEE.
FROM DOSSIER SEARCH TO MARKET READINESS
Set the product and country brief. Identify possible licensors and dossier opportunities; establish availability and the permitted scope of access.
Review the commercial case and arrange qualified assessment of dossier status, completeness, manufacturing and evidence gaps before licensing commitments.
Agree the licence or other rights model, responsible MAH arrangement, country pathway, local documents and a submission or transfer workstream where applicable.
Coordinate approved product information, artwork, supply readiness and the handover of ongoing regulatory, quality and pharmacovigilance responsibilities.
Qualified regulatory specialists assess whether a national, mutual-recognition, decentralised or centralised route is appropriate. The plan separates EU/EEA requirements from the national requirements of non-EU CEE countries.
The workstream can include CTD/eCTD gap review, local product information and submission coordination, depending on the product and the agreed authority pathway.
Confirm the eligible marketing authorisation holder and named owners for regulatory maintenance, pharmacovigilance, quality, manufacturing, supply and local market activities before implementation.
Licensing a dossier, transferring an existing authorisation and applying for a new authorisation are different routes. The agreed plan identifies which transaction and regulatory steps apply.
NUVELO HEALTH coordinates the opportunity search, commercial assessment, licensing preparation and implementation programme. The mandate identifies the qualified regulatory, legal, quality, pharmacovigilance and manufacturing parties responsible for specialist assessments, submissions, sign-offs and ongoing duties. Dossier access depends on owner agreement; authorisation and timing depend on the competent authority and product-specific evidence.
Search coverage, qualified opportunities, availability of dossier rights, closure of evidence gaps, country-readiness milestones and delivery against the agreed implementation plan. Forecast dates and budgets are reviewed when the dossier and pathway are known.
ILLUSTRATIVE ENGAGEMENT
A portfolio owner defines a medicine and target countries. Potential licensors are screened, dossier use rights and supply terms are assessed, and qualified teams establish the registration route and responsibilities for each country before commitments and launch preparation.
This describes a possible engagement, not a completed NUVELO HEALTH client project or an available licensed product.
START WITH YOUR PRODUCT AND MARKETS
Share a non-confidential outline of your target product, preferred countries and timing. Agree the scope of search and the specialist input needed.
Book a 30-minute introduction ↗ Send a dossier-search brief ↗