Smooth pharma product registrations
SCHOTT Poonawalla ensures that global regulatory services are observed to ensure all containment solutions are in compliance with country-specific laws and guidelines, as well as evolving international standards. This helps the manufacturers of drug products and medical devices to make sure that information about their containment systems is available for registration. Different countries follow different registration processes:
- In countries following Drug Master File (DMF) approaches, SCHOTT Poonawalla registers pharmaceutical packaging separately from the drug product and medical device.
- In many regions, including South America, the EU, and Australia, the owners of drug products and medical devices must submit pharmaceutical packaging documentation as part of their application dossier.