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MAH pour un médicament radiopharmaceutique au Japon
Notice published in French. The AI analysis summarises it for you in your language.
“I want this contract”: tracking, reminders and a bid file prepared by AI (eligibility, schedule, cover letter, technical proposal).
- Public buyer
- Institut National des radioéléments
Fleurus - Place of performance
- 6220 Fleurus, Hainaut
not published: buyer's address - Procedure
- Competitive negotiated procedure
You first submit an application; shortlisted candidates bid, then negotiate with the buyer. - Publication
- 4 August 2025
- Notice language
- French
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Description
Agir en tant que titulaire de l'autorisation de mise sur le marché (MAH ou représentant local) au Japon et gérer toutes les activités réglementaires, de qualité et de pharmacovigilance locales pour le générateur Ge/Ga-68 (le produit). Coordonner le processus d'enregistrement (New Drug Application « NDA ») du produit au Japon conformément aux réglementations et normes du MHLW (ministère de la Santé, du Travail et des Affaires sociales) et de la PMDA (Agence des produits pharmaceutiques et des dispositifs médicaux), ainsi que maintenir l’enregistrement. Importer et libérer le produit au Japon.
CPV codes
European codes that classify what the contract is about. They are how we find the tenders for your trade.
79000000
Winning prices for comparable contracts
- A quarter below
- €253,520
- Median
- €694,000
- A quarter above
- €3,166,661
Amounts awarded (excl. VAT) over the last 3 years for 92 contracts in the same CPV group (7900…), excluding framework agreements. Half of the contracts fall between the two quartiles. TED source: mostly contracts above the EU thresholds, so amounts tend to be high.
Likely competitors: who wins with this buyer in this field
- PQE BELGIUM · 1 contract won
- Global Regulatory Partners Inc. · 1 contract won
- FORECAST CONSULTING · 1 contract won
- CO Invest SAS · 1 contract won
- PAHRTNERS · 1 contract won
Partners and subcontractors
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Companies winning this type of contract in the region
- ARIA PARTNER SRL · 1 contract won in 3 years
- PQE BELGIUM · 1 contract won in 3 years
- Global Regulatory Partners Inc. · 1 contract won in 3 years
- PONCELET SIGNALISATION · 1 contract won in 3 years
- Briol & Partners SPRL · 1 contract won in 3 years
- CO Invest SAS · 1 contract won in 3 years
- PHARMACEUTICAL PROJECT MANAGEMENT SOLUTIONS · 1 contract won in 3 years
Possible partners for a temporary consortium or subcontracting… and competitors worth knowing.
Similar contracts already awarded
| Contract | Winner | Amount |
|---|---|---|
| Représentant local pour l’enregistrement DMF d’un API en Chine Institut National des radioéléments · 26 March 2026 |
PQE BELGIUM | €96,350 |
| MAH pour un médicament radiopharmaceutique au Japon Institut National des radioéléments · 20 February 2026 |
Global Regulatory Partners Inc. | €2,141,000 |
| Représentation générateur sur la France Institut National des radioéléments · 20 May 2025 |
CO Invest SAS | €432,000 |
| Consultance technique et stratégique en médecine nucléaire et en radiopharmacie Institut National des radioéléments · 14 March 2024 |
PHARMACEUTICAL PROJECT MANAGEMENT SOLUTIONS | – |
| Review of the data on the expansion of agricultural production areas onto forests and other land with high carbon stock for the purposes of the Renewable Energy Directive European Commission, DG ENER - Energy · 20 October 2026 |
FONDAZIONE CMCC | €451,800 |
Source : TED – Office des publications de l'Union européenne © Union européenne, données retraitées. Reference 510450-2025.