Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.
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| Title: | Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP. |
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| Authors: | Dave SK; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk Service Centre India Private Limited, Bangalore, India., Ørting C; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark., Roberts SW; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark. OSRB@novonordisk.com. |
| Source: | The AAPS journal [AAPS J] 2025 Oct 03; Vol. 27 (6), pp. 151. Date of Electronic Publication: 2025 Oct 03. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| ISSN: | 1550-7416 |
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| DOI: | 10.1208/s12248-025-01133-7 |
