Browsing by Subject Regulatory Affairs

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PreviewIssue DateTitleAuthor(s)
PDR00634.pdf.jpgMay-2020Comparative Regulatory Account on Post Approval Compliance of Us, South Africa and GCC CountriesWagh, Shravani R.
PDR00725_20MPH803.pdf.jpgMay-2022Comparison of Submission Requirements of Generic Drug and Medical Devices In Australia and CanadaPatel, Asaka A
PDR00614.pdf.jpgMay-2020Current Regulation of Drug Eluting Stent In USA, EU and IndiaParmar, Jenish John
PDR00738_20MPH809.pdf.jpgMay-2022eCTD Compilation and Dossier Preparation of Transdermal Drug Delivery System (TDDS) for US Market and Its Comparison with CANADABhamare, Shubham
PDR00519.pdf.jpgMay-2018Filing of Irbesartan Tablet 75 MG Module 3 ANDA SubmissionRaghuvanshi, Vinamrata
PDR00697_19MPH803.pdf.jpgMay-2021Identification and Implementation of Product Specific Standard For Orthopedic DeviceBariya, Divyesh
PDR00633.pdf.jpgMay-2020Lifecycle Management of Respiratory Products in Australia, New Zealand and Mena CountriesDesai, Priya
PDR00632.pdf.jpgMay-2020Manufacturing Design and Allingment with Regulatory Requirement As Per New Regulation Amended By CDSCOSoni, Krisha H.
PDR00636.pdf.jpgMay-2020Nutraceuticals Registration Requirements in GCC and SADC RegionRangwala, Tasneem
PDR00674_19MPH802.pdf.jpgMay-2021An Overview of Regulatory Requirements For API and FDF In Brazil, Vietnama and CIS CountriesJayswal, Dhruv
PDR00723_20MPH801.pdf.jpgMay-2022Post-Approval Management of An Anda Approved Drug ProductBhardwaj, Aakash
PDR00682_19MPH813.pdf.jpgMay-2021Preparation of Modul3-IIIContent for Sirolimus Polymeric Nanoparticles' (ANDA Product RAPCIN 1MG) Approval Process in USA and INDIAPatel, Khushboo
PDR00619.pdf.jpgMay-2020Regulatory Compliance Management and eCTD Compilation of Generic Transdermal Patche For US MarketKhandhara, Vraj Swetangkumar
PDR00728_20MPH808.pdf.jpgMay-2022Regulatory Framework and Understanding of Marketing Authorization of Drug - Device Combination Products in US RegionPathak, Pooja
PDR00617.pdf.jpgMay-2020Regulatory Information - Submission and Management (Article 57(2) of Regulation EC no. 726/2004)Suthar, Swastik Hasmukhbhai
PDR00676_19MPH806.pdf.jpgMay-2021Regulatory Landscape For Drug Registration Requirements and Procedure In China: An Emerging Pharmaceutical MarketDoshi, Mohit
PDR00679_19MPH810.pdf.jpgMay-2021Regulatory Perspective on Technology TransferSrivani, Yellamraju Sravya
PDR00673_19MPH801.pdf.jpgMay-2021A Regulatory Perspective To Streamline Rules, Regulations and Requirements For Importing Pharmaceuticals (Drugs And/Or Medical Devices) In Four Asian Countries: India, Nepal, Bhutan and SingaporeKulkarni, Apoorva
PDR00789_21MPH803.pdf.jpgMay-2023Regulatory Procedure of Post Approval Changes and Variation and Comparative Studies of European Union and United StateTailor, Jahnavi
PDR00618.pdf.jpgMay-2020Regulatory Requirement For Registration of Cardiovascular Drug in CIS CointriesPatel, Vidhi