Regulatory Services
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.
Drug Master Files (DMF)
For the USA, Canada, and China, SCHOTT Poonawalla has DMFs that cover all documentation related to the containment system and serve as a reference for the drug product and medical device application.
Global coverage – We support your pharma product registration globally via our expert network and processes to apply standard pharma industry dossier formats suitable for each country.
Reliable partner – We have a proven track record of applying best practices to ensure that dossiers match the relevant authority perspectives.
Always up to date – We continually monitor regulatory changes worldwide to assess their impact on registration requirements.
Direct contact – Our expert pharma regulatory support team is always available and on your side in the event of urgent authority enquiries.
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