We provide Regulatory services throughout Asia
You want to work with a team that has deep experience in registering pharmaceutical/Biotech products and in maintaining updated product licenses.
The alliance between AxxessBio and DKSH ensures a regional coordination of your company’s regulatory plan with crisp local execution.
We always look for “fast track” ways to register your products. Patient access to treatment is our main objective. Orphan drug registration is also important to consider.
All regulatory requirements for Named patient sales (NPS) or clinical trials importation are taken care of and managed by AxxessBio.
AxxessBio also coordinates post marketing surveillance, secures pharmaco vigilance operations and regulatory reporting functions.