Regulatory services

-Examples of services

  • Identification of regulatory requirements during development as well as life cycle management for chemical and biological drugs.
  • Writing of Module 3 sections, Quality Overall Summary and responses to authority questions.
  • Experience with marketing authorisation applications and clinical trial applications as well as ASMF/DMF and variation applications in EU+, Canada, US, Japan, China etc.
  • GAP analysis and evaluation of Module 3 sections against CMO manufacturing processes/QC and the current regulatory guideline.
  • Writing module 3 and QoS for  new marketing authorisation application

Cases

  • With a  customer, their partner  as well as the CMO manufacturing the drug product, a full module 3 and QoS was compiled and written.
  • GAP analysis of approved Module 3 sections against “current practice”
  • Current procedures at CMO and module 3 sections were compared. Further, an interview with the costumer and an on-site visit at the CMO were performed. This resulted in a prioritised list of GAPs with suggestions of how to handle each finding.
  • Orphan Drug: From a huge amount of data collected by scientists, the information was structured into a format that was suitable for filing to the authorities. This work included extracting relevant information from literature and selecting the required data from a large number of experiments.
  • Evaluation of Module 3: A customer was not sure if all sections would be acceptable by the authorities and needed an independent set of eyes to evaluate  where the biggest risks were in the application. A few high risk issues were identified and several suggestions for improvements were provided.

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