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Posted On: 02/26/2020 2:04:57 PM
Post# of 153889
Sjacobs.
Absolutely, one would think they have expertise in this area. From they achievements in Regulatory Affairs in 2019:
Amarex’s Regulatory Affairs department offers a competitive regulatory strategy to clients and maintains successful interactions with the US FDA and foreign regulatory bodies. In 2019, Amarex prepared and submitted 12 Investigational New Drug (IND) applications, six 510(k) applications, portions of a rolling Biologics License Application (BLA), one Drug Master File (DMF) application and one New Drug Application (NDA). Amarex also filed over 135 amendments to existing regulatory submissions and two of our clients had products approved.
Lets hope CYDY is part of their 2020 successes. However, this is not their first rodeo with the FDA and, hopefully, they know what they are doing
Absolutely, one would think they have expertise in this area. From they achievements in Regulatory Affairs in 2019:
Amarex’s Regulatory Affairs department offers a competitive regulatory strategy to clients and maintains successful interactions with the US FDA and foreign regulatory bodies. In 2019, Amarex prepared and submitted 12 Investigational New Drug (IND) applications, six 510(k) applications, portions of a rolling Biologics License Application (BLA), one Drug Master File (DMF) application and one New Drug Application (NDA). Amarex also filed over 135 amendments to existing regulatory submissions and two of our clients had products approved.
Lets hope CYDY is part of their 2020 successes. However, this is not their first rodeo with the FDA and, hopefully, they know what they are doing
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