Transfer and Registration

The factory is not a lab. What works in one place doesn’t necessarily work elsewhere. Scaling up the production? Moving it to a different site? Sometimes, you need to go back to your roots. We know where to look. We know what to fix.

Both scaling up a new product or transferring the production of an existing one might be a really challenging exercise. Process robustness may suffer over time. The original developers and knowledge of the original processes, as well as suppliers, might be long gone. Registration authorities will be asking tough questions. The regulations have become stricter.

We can help with special analytics as well as support in compiling the registration documentation and even in communicating with authorities. If needed, we can redevelop any part of the processes. We put as much effort into transfers as into any other processes, and we approach it with the same mindset as with new development.

Glenmark Pharmaceuticals

Our cooperation with Kapaji focused on technological support for a key project to improve production and analytical methods.Kapaji has provided a vital contribution with their technical knowledge, troubleshooting skills, and the development of a new method. A very welcome part was their professional communication, flexible hands-on approach, knowledge of local guidelines, and the ability to connect to different levels within the organization. From my side, I highly recommended them as a business partner.
Diederik Troost — European Director of Quality Assurance

API solid form​

  • Identification of CQAs and CPPs and their ranges (ICH Q8)
  • Equipment qualification (FAT, SAT, IQ, OQ, PQ)
  • Process flow diagrams
  • Contamination Control Strategy (Annex I)
  • Risk analysis, FMEA
  • Gap analysis for process and method transfers
  • QA documentation
  • Tech transfer project management
  • Serialization (registration with NMVOs in the EU, alert systems)

Support of API and drug product registrations

  • Registration strategy
  • Analytical method development, optimisation, and validation
  • ASMF and registration dossier gap analysis
  • ASMF and registration dossier compilation
  • Support for the registration process
  • Help with preparing the answers to deficiency letters (including experimental support)
  • Project management