Development Insights can assist your team in the development of an accurate filing with a consistent message by applying our expert eCTD authoring, reviewing, and publishing capabilities. Utilizing text guided templates, our Regulatory Operations group will provide training in the use of the templates to your authors. With input from your team, they will prepare a style guide for the filing, to ensure consistency between authors.
A submission timeline will be created, based on data availability for the authoring of each section, and a subsequent review schedule developed. Our team of experienced regulatory professionals can then develop the nonclinical, clinical, and CMC sections in eCTD format for your new drug and biologic applications (Investigational New Drug; IND and New Drug Application; NDA/BLA). We will ensure the creation of FDA Electronic Submissions Gateway (ESG) submission-ready regulatory documents that are compliant with International Conference on Harmonization (ICH).
Our publishing services are powered by Globalsubmit Publish, which is validated and maintained by Certara. Our publishing team will ensure:
For ex-US filings, our team can also provide technical development and submission preparation services for many different regions, including for example, European Medicines Agency (EMA) Investigational Medicinal Product Dossier (IMPD) and associated Clinical Trial Authorizations (CTA), as well as an ultimate Marketing Authorization Application (MAA) and Canadian Health Authority New Drug Submission (NDS), Quality Overall Summary (QOS) and Clinical Trial Application (CTA).