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Polypharma Registration Service, Our Ad-Hoc Service
End-to-end services provided by Polypharma Technologies & Sciences GmbH (Polypharma)include support for the registration process for generic medicines for Middle East and North Africa (MENA) markets.
For local generic pharma manufacturers to develop local production, Polypharma can 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.
Registration Service features
Technology transfer and registration of new generics
As an experienced pharmaceutical development, production and regulatory specialist, Polypharma has been supporting generic pharma manufacturers in Africa and the Middle East for more than a decade in all aspects concerned with bringing new drugs to market, including a Technology Transfer and Registration Service. This includes product planning, technical support for manufacturing process, technology transfer, scale-up, quality and marketing analysis, successful registration of drugs, and regular quality supervision of the production process.
Product planning covers a wide range of aspects in which Polypharma can provide advice and support. Its project planning services support partners according to their equipment, across all stages related to the development and production of generic pharmaceuticals, encompassing market analyses, feasibility studies, advice on product ranges to be manufactured, technology transfer of manufacturing and analytical processes, sourcing of raw materials for production of validation lots and industrial batches, supply of reference substances and reagents required at the analytical level and HPLC columns needed for liquid chromatography analysis.
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 in all the key regulatory compliance aspects, including weighing & preparation of raw materials, production, filling and primary packaging, and secondary packaging.
During these processes, Polypharma technical teams work in close liaison with partner production and analytical teams on such aspects as analytical validation, process verification, storage inspection, quality control testing, environmental checking, and in-process trouble shooting.
By implementing the first production jointly, Polypharma can carry out in-process troubleshooting with the production team in advance, with minimal bureaucracy to allow production of the generic product to be implemented smoothly.
When upgrading to industrial-scale manufacturing, 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 pharma product 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.
Where scale-up in the production process from a smaller batch quantities to production quantities is required, Polypharma’s scale-up service can provide advice on manufacturing steps to be taken, with technical experts to support local production teams.
Polypharma’s developed drug dossiers and drug master files (DMFs), describe the complete analytical approach of the active substance and finished drug. Polypharma expertise encompasses the three consecutive analyses involved in drug registration: active substance analysis, analysis of production lots, and analysis of stability lots.
- Active substance analysis: carried out directly on each incoming delivery and, if longer storage is involved, repeated before use in the manufacture. When active substances are listed in a pharmacopoeia, Polypharma can specify the analytical methods and specifications demanded.
- Analysis of production lots: The analysis of production lots is carried out by Polypharma in collaboration with local analysis team directly during the technology transfer. Here, validation lots are jointly analyzed directly on site and the conformity of the generic drug product is ensured.
- Analysis of stability lots: Similar in specification to analysis of production lots, this is crucial to achieving successful marketing authorization. According to the ICH guidelines, an investigation of the medicinal products by long-term stability tests, as well as by accelerated, 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 pharma product when stored under excessively high temperatures and humidity.
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 commercialize these generic pharmaceuticals and biopharmaceuticals under their own labels.
In addition to the CTD formatted drug dossier, a DMF for the active ingredient is 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 when required.
Many biosimilar developers need to think outside the box when structuring their clinical trials. As an example, one could discuss with a supervisor whether it is insufficient to investigate only one indication in the comparative efficacy study and rely on extrapolation for the remaining indications.
Polypharma has developed registration of drugs expertise, including dossier services based on extensive market research and client consultations across the MENA region, serving markets that lack organic production capacity and that are also poorly served by European and American based manufacturers.
Whenever a target medicine or drug is identified, Polypharma can assist a production partner with registration of drugs, developing tailored generic pharma drug dossiers to be available for local registration.
Click on Polypharma Technology transfer and registration service for further information.
Click on Polypharma Full Service to Production for further information on production support.
Click on Polypharma support for registration process for thought leadership articles.