perfect
support.
Our highly trained and experienced R&D team is capable of offering support in all stages of development. From formulating and validating methods of production and analysis, to creating part II of registration files. Our determined experts are at your service to help you bring a high quality product to market.
We offer an unique service: everything is done in-house by determined experts.
From idea to registration, we offer support.
For existing registrations we can help you quickly transfer your products to Produlab Pharma.
With our 'method transfers' with related validations, together with our own production facilities, we can offer you a full product transfer within 3 to 6 months.
Expand or update an existing registration? That is also part of our support.
For new registrations we can support you in developing the composition and galenical form. Furthermore we can help develop the related methods of analysis. After finishing the development, all methods (including production) are validated. Pilot scale batches can be produced in our ultramodern production facilities. All analysis is done in our in-house lab, which requires no external analysis or producer. This ensures speed, flexibility and high quality.
Extensive shelf life studies
(Ongoing stability studies according to VICH)
Both existing and new registrations are tested for stability in our laboratory. Your products are stored in our climate chambers and tested periodically as agreed. The results of these studies are used for registration or for substantiation of constant quality.