S.No | Name of the Student | Guide | Project Title |
1 | Praveen T S | Dr. R. Kamaraj | To Evaluvate the Impurities content on Drug Products Based on Risk Assessment as per ICH Guidelines |
2 | Jyothika T | Dr. R. Kamaraj | Comparative Study of Medical Device Vigilance System between EU, US and India |
3 | Dineshkumar M | Dr. R. Kamaraj | Regulations and operational Process for the approval of Biopharmaceutical as per USFDA, EU and DCGI |
4 | J rashi | Dr. R. Kamaraj | Management Stratagies Innvolved in the development of Biosimilar and Regulatory Approval Process in USFDA |
5 | Subhadarshini bhagyashree | Dr. R. Kamaraj | Current Requirements and Challenges in Regulatory Approval Process for Medical Device as per International Council for harmonization |
6 | Archana panigrahi | Dr. R. Kamaraj | Regulations of USFDA Abbrevated New Drug Applications Marketing Authorization of AMNOCAPOIC ACID Tablets USP 500 Mg and 1000Mg |
7 | Kavya S M | Dr. R. Kamaraj | To Study the Regulatory Requirements of the Finished Drug Products for the Selected Emerging Markets |
8 | Praveenkumar S | Dr. R. Kamaraj | Development and Regulatory Requirement for Chemistry Manufacturing and Control of Ibuprofen 200mg Capsules for USFDA |
9 | Tamil azhagan V | Dr. V. Manimaran | FDA’s Procedure for Approving and Revoking Emergency use Authhorization (EUA) |
10 | Shankar ganesh K | Dr. R. Kamaraj | Development and Regulatory Requirement for Chemistry Manufacturing and Control of Prasugrel 5MG Tablets for USFDA |
11 | Nanbban R | Dr. R. Kamaraj | Development and Regulatory Requirement for Chemistry Manufacturing and Control of Esomeprazole Magnesium oral Suspension 40 MG for USFDA |
12 | Panga yamini | Dr. R. Kamaraj | To Study USFDA and EU Post Approval Quality Assessment Requirements of Drugs |
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