Polypharma CTD Common Technical Document support

End-to-end services provided by Polypharma Technologies & Sciences GmbH (Polypharma) include specific support for compiling the Common Technical Document (CTD) that forms the core of regulatory approval submissions for new products, including generics.

Polypharma’s extensive portfolio of pre-developed generic and biosimilar drug dossiers cover all dosage and delivery formats required by generic drug manufacturers, with an emphasis on the needs of emerging markets in the Middle East and North Africa (MENA) region.

These off-the-shelf dossiers are accompanied by the technical documentation required by regulatory authorities for product registration and fast-track marketing approval. These include the API Drug Master Files (DMFs) and modular CTD dossier formats required for regulatory approval, including the EU technical documents (EUCTDs) and electronic technical document eCTD modules 1-5 required for online paperless eCTD submission.

CTD modules

Polypharma has developed its regulatory Polypharma CTD Common technical document supportand technical support services that are optimized to the requirements of the MENA region, where markets are typically poorly served by Big Pharma manufacturers, while also lacking their own organic production capacity. These factors raise needs for fast-track turnkey drug dossier development and end-to-end support from identified need to full production.

Whenever a target medicine or drug is identified, Polypharma can support a drug 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. These include:

• Unit composition and manufacturing formula
• Manufacturing equipment & process
• Quality control of active ingredient (specifications, analytical methods)
• Quality control of excipients (specifications, analytical methods)
• Quality control of the finished product (specifications, analytical methods)
• Packaging Information
• Stability Data.

Where necessary, the CTD dossiers can also include Well Established Use (WEU) and Clinical Overview (CO) sections to support submissions, including all five demanded modules to comply with ICH guidelines  standard  Common Technical Document format, or the eCTD formats that are increasingly demanded by regulators for electronic exchange.

This service provides MENA drug companies without their own R&D departments with the possibility of registering and producing innovative and classic generics, supporting them to overcome drug supply problems and counterfeiting problems in these markets.

Furthermore, Polypharma’s ongoing customer care package can also handle dossier updates for extended product lifecycles.

Dossier Development Service benefits

Polypharma’s Dossier Development Service is based on the company’s many years of experience in advising generic manufacturers in Northern, Western and Eastern Africa, as well as in the Middle East.

It can play a key role in supporting local partners rapidly respond to supply shortages, therapeutic gaps and consequent market opportunities.

In particular, it provides production partners with access to Polypharma’s extensive panel of pre-developed generics and biosimilars without having to outsource production to a CDMO.

Resources

Click on Polypharma Generic Dossier Development to learn more.
Click on Polypharma portfolio of human generics and biosimilar dossiers for further information.
Click on Polypharma portfolio of veterinary generics for further information.
Click on ICH M4 Common Technical Document (CTD) for background information.