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[RegAffairs]Re: Submitting US dossier to EU
Raj, This is a bit too complicated to generalise. I would need to know product specifics to make a recommendation. The reference product is perhaps the most serious concern, but of course the other issues you mention also need to be taken into account. I would suggest that you obtain advice from a good consultant as to your specific products. Good luck! Kind Regards, Pete Peter Lassoff, Pharm.D. Vice President, Europe PAREXEL Consulting Email: Peter.Lassoff@parexel.com |
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