Guidance on regulatory submissions and queries

Clinical pharmacology/ pharmacokinetic, immunogenicity data and bioanalytical data on response to treatment and patient-specific genomic biomarkers are described in regulatory documents (e.g. IB, IND, IMPD, CTD, briefing documents for any authority meetings).

Ando supports regulatory teams

in writing regulatory documents

closely cooperates with the client´s regulatory team to meet the regulatory strategy and anticipated timelines

carefully reviews all relevant information to a drug development product to put the data into the right context

provides text suggestions

supports the preparation of questions to authorities

Ando provides guidance on response to regulatory queries dealing with clinical pharmacology/ pharmacokinetic, immunogenicity data and bioanalytical data on response to treatment and patient-specific genomic biomarkers.

carefully reviews regulatory queries

puts queries into the context of current regulatory guidelines

provides reasonable recommendations on how to handle the queries

discusses the suggestions with the regulatory/ clinical teams

suppports operational implementation of additional investigations should these be required.

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Nordre Strandvej 119D,
3150, Hellebaek, Denmark
+45 2568 3668
anke.domdey@andobio.com

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