Support of regulatory submissions and handling of queries

Establishing a fruitful dialogue with regulatory authorities supports progressing drug/ vaccine development especially in case of new treatment modalities, where the development program is specific and standard guidance is not available. Scientific advice by regulatory authorities is valuable already at early development stage.

How we support regulatory submissions and handling of queries

We support any preparation of regulatory documents with respect to the description of non-clinical studies and clinical pharmacokinetic and immunogenicity studies and we help our clients tackle queries by regulatory authorities. Given our bioanalytical know-how, we put the outcome of PK and immunogenicity studies into perspective with the bioanalytical methods used for determination of the drug and investigation of anti-drug antibody formation. We provide text suggestions for documents like IB, IND, CTA, IMPD, CTD or questionnaires and briefing information for preparation of meetings with regulatory authorities (FDA, EMA, EU national).

Summary of nonclinical study designs, results & conclusions

Summary of clinical pharmacokinetics and immunogenicity studies

Identification of key questions to early development meetings with regulatory authorities

Preparation of briefing documents to early development meetings with regulatory authorities

Support to handling of regulatory queries

Stengthening the position towards regulatory authorities

We also participate meetings with regulatory authorities, if asked for. In case of regulatory queries, we usually suggest various options and put these into perspective with regulatory/ development risks.


Nordre Strandvej 119C,
3150, Hellebaek, Denmark
+45 2568 3668