A hand tapping on a laptop next to three pharmaceutical vials

Regulatory Services

Support for the integration of primary pharmaceutical packaging content into drug and medical device registrations
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.
SCHOTT Regulatory Services - Drug Master File
Icon about us 05 Num of plants

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.

Icon betreuung durch expertinnen

Reliable partner – We have a proven track record of applying best practices to ensure that dossiers match the relevant authority perspectives.

Icon improve time to market

Always up to date – We continually monitor regulatory changes worldwide to assess their impact on registration requirements.

Icon no registration

Direct contact – Our expert pharma regulatory support team is always available and on your side in the event of urgent authority enquiries.

Mahesh Italiya.png
Mahesh Italiya, SCHOTT Poonawalla Quality Head
When urgent FDA inquiries threaten to interrupt client manufacturing schedules, the SCHOTT Poonawalla team is immediately at their side with their expertise to resolve the issue.

Get in touch

Mahesh Italiya

Mahesh Italiya

Quality Head

*Field is required

SCHOTT Poonawalla will use your data only for reacting to your inquiry. Find more information about processing your personal data in SCHOTT Poonawalla’s data privacy policy

I agree that SCHOTT Poonawalla may send me e-mails with information on products and services of SCHOTT Poonawalla. My data will not be passed on to third parties. After registration, I can revoke my consent at any time at the SCHOTT Subscription Center following the link in each email footer.