Technology transfer and registration service

Technology transfer and registration of new generics

As an experienced specialist, Polypharma has been supporting generics manufacturers in Africa and the Middle East in:

  • product planning
  • the manufacturing process
  • its analysis
  • the registration of drugs

Annual supervision of the production process can be carried out.


Product planning

The topic of product planning is a very comprehensive aspect in which Polypharma will be happy to advise you. You can find more information on this in the project planning section.


Manufacturing process

Technology Transfer

The manufacturing process service includes a technology transfer at the moment of manufacturing the validation lots for the registration process.

For joint quality control, Polypharma supports the manufacturing process as follows:

Weighing & preparation of raw materials




Filling / packing in primary packaging


Packing in secondary packaging

During this process, our technical team works hand in hand with your production and analytical team on:

  • Analytical validation
  • Process verification
  • Storage inspection
  • Quality control testing
  • Environmental checking
  • In-process trouble shooting

By implementing the first production jointly, Polypharma can carry out in-process troubleshooting with the production team in advance, without bureaucracy, so that the production of the generic product can be implemented smoothly.


Scale-Up Service

When upgrading to larger production machines, it is particularly important to review the production process from the beginning. The machines must be adjusted to produce the specific generics and the quality of the generic must be controlled against the defined fill quantity and dosing specifications. In addition to the benefits of faster production due to larger batches, it is equally important to consider that the changeover will, among other things, increase mixing times to ensure homogeneity.

If a changeover in the production process from a smaller batch quantity to a larger batch takes place, we will be happy to advise you on how this step can be taken and can support your production team with our technical team.




In our drug dossiers and DMFs, the complete analytical approach of the active substance and the finished drug is described.

There are 3 consecutive analyses in which Polypharma can assist with its knowledge:

Active substance analysis


Analysis of production lots


Analysis of stability lots

Active substance analysis

Analysis of active substances should be carried out directly on each incoming delivery and – in the case of longer storage – repeated before use in the manufacture of medicines.

If the active substance in question is listed in a pharmacopoeia, we will provide you with the analytical methods and specifications prescribed there, which your analytical team can use to examine the active substance.


Analysis of production lots

The analysis of production lots is carried out by Polypharma in collaboration with your analysis team directly during the technology transfer. Here, validation lots are jointly analysed directly on site and the conformity of the generic product is ensured.


Analysis of stability lots

The analysis of the stability lots does not differ in the analysis of the production lots, but is of enormous importance for the submission of the dossier for marketing authorisation.

According to the ICH guidelines, an investigation of the medicinal products by long-term stability tests, as well as by stress tests, is necessary in order to be able to demonstrate the compliance of the medicinal product over the shelf-life period and to be able to assess effects on the generic product when stored under excessively high temperatures.


Drug approval

Polypharma acts as a consultant in the drug approval process. This service is available to generic manufacturers in Africa and the Middle East who have received a dossier from Polypharma and wish to commercialise these generics under their own label.

Basically, in addition to the CTD formated drug dossier, a DMF for the active ingredient used is also required, as well as other documentation on the active ingredient, such as:

  • a GMP / CPP and
  • a manufacturing authorisation

Polypharma can provide all* relevant documentation for registration. You can find more information about this service under delivery of raw materials.


*A bioequivalence study can be carried out on request and is associated with additional costs.

Technologies & Sciences GmbH

Grosse Reichenstrasse 27
20457 Hamburg
+49 (0)40 37 480 3-0