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Polypharma R&D Support for Drug Development
Polypharma Technologies & Sciences GmbH (Polypharma) provides end-to-end pharmaceutical consultancy and support services that lighten the research & development burden and reduce R&D costs for companies establishing new products and local production for markets across the Middle East and North Africa (MENA) Region.
These services include dossier development for generic medicines that require considerable analytical research and development effort in the areas of testing and target validation. Furthermore, Polypharma can support MENA drug companies without their own R&D departments in registering and producing innovative and classic generics.
Polypharma’s drug dossier service is based on extensive market research and client consultations across the MENA region as well as the full pharmacopeias and regulatory regimes worldwide. This knowledge can be applied to target discovery and target identification for drugs that can be locally manufactured.
Whenever a desired medicine or drug target is identified, Polypharma can support a pharma production partner develop a tailored generic drug dossier to match that need and be available for local registration.
Polypharma can develop drug submission dossiers and drug master files (DMFs) that include all the technical data demanded by regulators, including unit composition and manufacturing formulae, compliant manufacturing equipment & processes, stability data, specification and testing quality control of active ingredients, excipients, and finished product,
Once the dossier and DMF are accepted, Polypharma’s research and development capabilities can be harnessed for tech-transfer to accelerate production at the partner’s own production facility, as well as a full service to move partner from development to full scale production.
Technical R&D company support can involve providing all raw material documentation required for registration and providing all necessary information to meet legal provisions.
Polypharma Full Service offerings can include all these elements and more to provide a total solution for pharmaceutical developers and producers that can also include processing registrations, with on-site services that include all necessary API-manufacturer documentation, such as GMP, CPP, manufacturing license, and DMFs.
Polypharma partners with selected companies who can develop sufficient and reliable local production, and developing detailed design and development processes to support supporting companies in the MENA market in generic pharma production of medicines, drugs, and biosimilars.
The company has many years of experience in advising generic manufacturers in Northern, Western and Eastern Africa, as well as in the Middle East.
Polypharma aims to act as a close partner in client R&D projects in all stages of the design development process to support customers according to their current equipment levels, in all stages related to the production and marketing of generics.
These project planning and facilitation services can encompass advice on products to be manufactured, establishing project timelines with milestones and KPIs, and identification of reference substances and reagents required at the analytical level, as well as supply of research materials needed to support R&D projects.