Browsing by Subject Regulatory Affairs

Jump to: 0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
or enter first few letters:  
Showing results 1 to 12 of 12
PreviewIssue DateTitleAuthor(s)
PDR00843_22MPH805.pdf.jpgMay-2024Comparative Study on Current Regulatory Requirements for Generic Synthetic Peptide Based Drug-Device Combination Products in U.S. and EuropePandya, Khushi
PDR00840.pdf.jpgMay-2024A Comparison of Variation Filling Approaches in South Africa and Botswana’s Legal FrameworkDesai, Drashti
PDR00844_22MPH806.pdf.jpgMay-2024Formal Meetings Between USFDA and Applicants of Complex Products Under GDUFA and PDUFAShah, Khushi
PDR00848_22MPH810.pdf.jpgMay-2024Generic Drug Product Registration in Ukraine to Align with the EMA Regulation: A Case Study of Mycophenolate Mofetil and Module 3 CTD Preparation for SubmissionModi, Sharvil
PDR00846_22MPH808.pdf.jpgMay-2024Image Oncology: A Regulatory PerspectiveAdodariya, Meet
PDR00842_22MPH804.pdf.jpgMay-2024Post-Approval CMC Changel in Brazil and EuropeShah, Gaurang
PDR00839.pdf.jpgMay-2024Preparation and Validation of CTD and eCTD for an ANDA of a Model Tablet as per USFDA RequirementsPatel, Aneri
PDR00847_22MPH809.pdf.jpgMay-2024Proton Therapy and It's Regulatory Framework in IndiaSingh, Ruchi
PDR00849_22MPH811.pdf.jpgMay-2024Regulatory Compliances for Food and Nutraceuticals in USAKalola, Utsav
PDR00841_22MPH803.pdf.jpgMay-2024Regulatory Pathway for Registration of ORS with Zinc in Domestic Market and its Comparison with African Countries and The Regulatory Perspective of Real-World Data in the US, Europe, and the UKVaghela, Gargi
PDR00850_22MPH812.pdf.jpgMay-2024Regulatory Requirement and Re-Registration of Pharmaceutical Products in the Republic of MoldovaPatel, Yesha
PDR00845_22MPH807.pdf.jpgMay-2024Regulatory Strategies and Requirements for Registration of Innovator Drug Products Entering Latam Contries: Mexico, Peru, Equador and ChileKulkarni, Mandar Arvind