of development and production
Preparation, selection and characterization of solid forms of API
Support in the preparation of patent applications
Special in vitro testing
Support of formulation development
Standard and above-standard analytics
Synthesis of API, standards, impurities, evaluation and support of syntheses
Preclinical in vivo testing
Transfer and registration
Support of GMP activities
Support of method and process transfer
Equipment qualification (IQ, OQ, PQ)
Analytical method development and validation
Contamination Control Strategy
(Volume 4 Annex 1)
Compilation of API and drug product registration documentation
Validation of computer and automated systems, qualification of IT infrastructure
Data integrity, validation of laboratory equipment with software
Even though the pharmaceutical company Noventis s.r.o. has been collaborating with Kapaji for a relatively short period of time, we had a great opportunity to look at the issues we were facing from a non-biased perspective. This approach was ground-breaking as it notably helped us in our professional development and tackling the long-lasting problem.
We were astonished how well-prepared and acknowledged they were even before the first meeting in Zlin, Czech Republic. The extensive trouble-shooting process could thus be completed in two days, where we analytically examined the individual steps in the production. Consequently, we were able to evaluate all potential critical points not only from the manufacturing process, but also in the overall company structure. Last but not least, we appreciate Kapaji for combining technical expertise with enthusiastic dealing with obstacles.
We would like to express our gratitude towards Kapaji’s excellent assessment technique as they are an inspiration for the further development of our company.
Altogether 30 years' experience in big pharma with expertise in project management, including very complex projects across several continents.
Responsibility for a project office with a portfolio of 150 projects in chemical and pharmaceutical development, end-to-end, from ideation till launch and routine production.
Implementation and optimisation of company processes, from small to big, from core team to corporate matrix.
Foundation and leading of The Parc, an industrial–academic cluster.
None in the world can give you what I can promise. Karel's Grandpa
I do not give promises. Karel
The happy employee makes the customer happy, and the happy customer makes the shareholder happy – trust brings more than control.
Nothing is impossible if you can imagine it. That’s what science is all about.
Prof. H. J. Farnsworth