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You are a biotechnology or cell therapy company, located in the US, Canada, South Korea or Japan, searching for European suppliers or partners to help you determine and choose optimal clinical supply or commercial biomanufacturing facilities in the European Union.

An optimal cGMP facility may be owned and operated by a Contract Manufacturer Organization (CMO), a Contract Research Organization (CRO) or could be an available space that you might acquire or lease.

Biotech Consult can layout the manufacturing landscape and possible options for the expansion of your business into the European Union, taking into account the biologistics issues and solutions providers (major airports, road, train).

Based on a first exhaustive list and features determined with you, Biotech Consult can select a short list and recommend the best suited manufacturing sites and infrastructures.

You can afterwards qualify those infrastructures by yourself or execute that work through our services.

Biotech Consult can further qualify the European biotech manufacturing actors with its dedicated partners :

• Biologistics options and costs : Intraco
• Labor and environmental laws, government regulations and tax, customs, licensing/accreditations : Bird & Bird

European overview of the available cell therapy or biologics manufacturing facilities, e.g . CMOs, institutional infrastructures (university hospitals, blood banks,…) or even private companies with overcapacities, whatever their size and specific biologics manufacturing expertise may be.

Deliverable : File featuring ~25 dedicated sites, classified by location (country/city), GMP area surface (and class B-C-D range if available), non GMP area surface, licensed manufacturer accreditation date and focus-expertise (and references if available).

• Selection and prioritization, in collaboration with your staff, of ~10 manufacturing sites, located in the preferred area .
• Contact with the 10 selected CMOs for NDA, project leader identification and non-confidential inquiry, by phone, in order to complete the initial file.
• Establishing and sending the qualification questionnaire to the identified CMO project leader.
• Review and further exchanges by emails/call on the basis of the information gathered.
• Selection and prioritization, in collaboration with your staff, of a short-list of 5 best suited manufacturing facilities.
• If needed, visit of those facilities in order to check the questionnaire answers and on site biologistics.