The Premier Consulting Blog

APRIL 27, 2023

offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and adapting to these improvements will be mandatory across all major regulatory authorities by 2028 (earlier, in many regions). Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions.

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Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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Perficient: Drug Development

SEPTEMBER 19, 2023

jobs by 2028. This solidifies that Salesforce is leading the charge in AI, and Perficient is leaning into the partnership to bring innovative solutions to our clients. We learned about new Salesforce capabilities and technologies, heard new product announcements, and connected with peers and clients from across industries.

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Agency IQ

JUNE 17, 2024

To support the extension, the request also noted the extended transitional periods for medical devices and diagnostics though December 31, 2028. In the new standardization request, this standard has a deadline of 2024 for IVDR (Annex II) but 2028 for MDR (Annex I). Another discrepancy is the symbols standard, ISO 15223-1.

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Agency IQ

JUNE 7, 2024

Applicants have until June 19, 2028 , “individually or collectively,” to submit the application to the assigned RMS ( Article 8 ). Finally, companies will then have until June 19, 2028 , to submit applications for approval of the work program-listed substances to the assigned RMS.

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The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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Agency IQ

JUNE 28, 2024

Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. The CORE-MD project contributed significantly to what clinical evidence for orphan and pediatric devices should look like.

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