Regulatory Support

Regulatory Support

Every development or transfer project must be approved by competent authorities prior to implementation. In order to keep approval times short, all existing regional and upcoming regulatory requirements need to be considered as early as possible. On this basis development efforts will:

  • Focus on generating relevant & complete dataset required for approval
  • Avoid costly and time-consuming delays due to unsuitable or missing development data
  • Help to minimize the cost of post-authorization CMC changes by controlling the level of detail in the registration dossier and taking advantage of the flexibility that is offered by ICH Q8, Q10 or Q12 guidelines.

In addition to the above, we support updating of outdated dossiers (GAP analysis, dossier-update, variation strategy, variation filing) to prepare for new marketing authorisation applications.

Our regulatory support covers activities during

  • Product development
  • Clinical studies
  • Product life cycle management
  • Technology transfers
Product Development
Clinical studies
Product life cycle management
Technology transfer
  • Support of development projects to ensure that all regional regulatory requirements are considered
  • Determine the most appropriate application type for a market authorization application with respect to clinical data requirement and time-to market (e.g. full / mixed / hybride / well-established use / generic dossier)
  • Analyse opportunities for study waivers (BCS-classification, use of in-vitro systems) and writing of biowaiver justifications
  • Support development strategy (size and number of batches, stability designs, setting of specifications)
  • Alert on new and relevant upcoming regulatory requirements
  • Compile regulatory expert statements (e.g. module 2.3)
  • Provide appropriate IMPDs and conclusive registration documentation in eCTD format ready for filing
  • Professional management of corresponding regulatory procedures (such as: filing, tracking, responses to deficiency letters)