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[RegAffairs]Re: EU GMP certification
I think nobody will inspect your facility without the reference of a dossier (MAA/DMF/CEP). You can request anyone of European authority for inspections for your facility. First condition is your API should be approved and marketed in that particular country. Only problem here is that authority will give least priority to API facility inspection and it may take too much of time for inspection. thanks, Ketan |
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