Polypharma research on new molecules supported by R&D team

End-to-end services provided by Polypharma Technologies & Sciences GmbH (Polypharma) include support for development of new molecule-based drugs for Middle East and North Africa (MENA) markets.

The development process can be fully supported by Polypharma’s expert Research & Development Team.

Regulatory Support

Development of new molecules can be applied for human and veterinary medicines, generics, biosimilars or food supplements.

The development service includes a full scientific R&D exploration, along  with support for development of DMF (Drug Master File) and registration procedure.

End-to-end service

Whenever a target new molecule medicine is identified, Polypharma can support a production partner with registration of consequent medicines, developing tailored generic pharma drug dossiers to be available for local registration.

For local generic pharma manufacturers to develop local production, Polypharma can also provide advice and support for new manufacturing processes, also including technology transfer, manufacturing of ‘proof’ batches required for regulatory validation lots and marketing registration, along with relevant registration documentation.

In addition to the CTD formatted drug dossier, a DMF for the active ingredient used is usually also required, as well as other documentation on the active ingredient, such as GMP/CPP approval and manufacturing authorization.

Polypharma can provide all relevant documentation for registration, including bioequivalence study where required.

Resources

Click on Polypharma New Molecules for further information.
Click on Polypharma support for registration process  for thought leadership articles.