Technology and analytical methods
A properly developed technology for the manufacture of a medicinal product is the key to achieving the goal of obtaining marketing authorization. At the same time, it ensures that manufacturing problems with routine production to the market and the number of rejected batches are reduced to minimum.
It is important to thoroughly check the quality of planned technology, which can only be done using well-develop analytical methods for medicinal product testing. Only a properly designed and validated method can be considered suitable for its intended purpose.
Yet, method and technology transfers are another important aspects to highlight. Sometimes for purely business reasons, and sometimes as a result of the closure of a laboratory or manufacturing site, there is a need to transfer methods and technology to a new place.
At SciencePharma we have widely experienced CMC and GMP experts who will be happy to advise you on all aspects of technology and analytical methods:
- Analytical method validation taking into account ICH Q2 Validation of Analytical Procedures: Text and Methodology guideline
- Analytical method transfer for chemical, biological and biotechnological products
- Manufacturing process validation taking into account EMA Guideline on process validation for finished products
- Technology transfer – with our help you can transfer technology and methods from one end of the world to the other.
The scope of our support is tailored to the individual needs of our Client.
Write to us and we will choose the most suitable solution for you!