Guide to drug regulatory affairs

Պահպանված է:

Մատենագիտական մանրամասներ
Հիմնական հեղինակ:	Friese,Brigitte
Ձևաչափ:	Գիրք
Հրապարակվել է:	Germany Editio Cantor Verlag Aulendorf 2007
Խորագրեր:	Drug regulatory affairs aPharmaceutics
Ցուցիչներ:	Ավելացրեք ցուցիչ Չկան պիտակներ, Եղեք առաջինը, ով նշում է այս գրառումը!

Նմանատիպ նյութեր

Drug Regulatory Affairs
‌: Singh
Հրապարակվել է: (2023)

Drug Regulatory Affairs
‌: Gajendra
Հրապարակվել է: (2023)

Drug Regulatory Affairs
‌: Itkar, Sachin
Հրապարակվել է: (2022)

Drug Regulatory Affairs (PB)
‌: Bigoniya
Հրապարակվել է: (2019)

FDA REGULATORY AFFAIRS
‌: MANTUS DAVID
Հրապարակվել է: (2021)

"Part I Regulatory Policy Framework for Entrepreneurship with Pharmaceutical Avenues Part II Hands-On Experience at Regulatory Affairs Department of Cipla"
‌: Vasmatkar Mahesh

Drug metabolizing enzymes
‌: Lee,Jae S
Հրապարակվել է: (2014)

"Part I - Analysis of Regulatory framework for Nanopharmaceuticals in the US, EU and India. Part II - Regulatory Affairs and Dossier Management at Cipla Ltd"
‌: Patel Aiman

"Part I - Regulatory Considerations for Biologics Approval Processes in USA, India and EU Part II - Exploring Regulatory Affairs and Global Submissions "
‌: Pawar Srushti

"Part I - Regulatory Framework and Innovations using 505(b)(2) Pathway in Drug Development and Approval Part II - Internship at Bliss GVS Pharma in Regulatory Affairs Department- US Market"
‌: Patel Astha

"Part I - Regulatory Framework for Coronary Stents in Regulated and Semi- Regulated Countries. Part II - Understanding Regulatory Submissions: Ensuring Global Regulatory Compliance"
‌: Tyagi Somya

"Part I - Regulatory Compliance Leveraging Artificial Intelligence - A comprehensive Study of Opportunities and Challenges Part II - From Analytical Profiling to Regulatory Affairs - Stability, Assessment, Forced Degradation and RA Submissions for Emerging Markets "
‌: Mulla Sahil

Part I - Regulatory Framework for Development of Paediatric Formulations Part II - Exploring Regulatory Submissions in Emerging Market
‌: Dand Chandni

"Part I Comparison of Regulatory Considerations for Repurposed Drugs in US, EU, & India Part II Optimizing Regulatory Processes Enhancing Product Life Cycle Management from Initial Filimg to Post-Approval"
‌: Bajaj Aanchal

"Part I - Eurasian Economic Union: Analyzing Drug Registration Pathways, Dossier Requirements and Comparison with European Union's Regulatory Frameworks Part II - Implementation of Regulatory Practices for Pharmaceutical Submission in the European Union"
‌: CP Keerthana

Part I - Comprehensive Evaluation of Food Defects as per FDA: A Statistical Analysis Part II - Global Regulatory Affairs: A Practical Approach to Dossier Preparration, Gap Analysis, Query Resolution and Documentation
‌: Pawnikar Vaishnavi

Part I Real World Evidence for Regulatory Decision Making: Indian Framework Part II Navigating the USFDA Regulatory Landscape: Insights from Theory to Application
‌: Gupta Adarsh

"Part I - Regulatory Considerations of Nitrosamines: Exploring Mutagenic and Impurities and Genotoxicity in Pharmaceuticals Part II - Navigating Regulatory Frameworks : A practical Approach To Global Compliance"
‌: Gharat Sejal

"Part I - Regulatory Framework and Market Dynamics of Nutraceuticals in Major International Markets Part II - Developing Dossier and Regulatory Submission Strategies for Pharmaceutical Market Authorization in the European Union."
‌: Bose Anushree

"Part I - Regulatory Perspective and Strategies to Strength and Speed Ip Commercialization Process Part II - Dossier Preparation and Regulatory Compilance in ROW: A Pratical Approach in Ajanta Pharma"
‌: Dwivedi Priyam

Part I - Regulatory Frameworks for Generic Drug Applications and to Identify the Filing Discrepancies Part II - Internship Experience: Documents Required, dossier Preparation and Deficiency Analysis
‌: Pawar Jyoti

"Part I Nisin-Silver Nanoconjugate in Polymeric Microneedles for Antimicrobial Action and Regulatory Aspects of Microneedles in India, USA and Europe Part II Navigating USFDA and CDSCO Regulatory Requirements and Hadling the Documentation Approaches"
‌: Domb Dnyaneshwari

Part I - Harmonisation of Orphan Drug Regulations: Comparing Indian Regulations with US and EU Regulations Part II - Internship Experience Document Review, Dossier Compliation Process for Regulatory Submission in Iraq
‌: Gubare Uddesh

"Part I Regulatory Pathway And Formulation Strategy For 505(B)(2) Filing Of Oral Dispersible Strips In Anti-Epileptic Therapy Part II Navigating the Regulatory Compliance at Glaxosmith Kline Pharmaceuticals Limited for General Medicine Products Concerning Licenses and Best Practices"
‌: Nair Keerthi

Drug regulatory affairs
‌: Vyawahare, N.S
Հրապարակվել է: (2020)

"Part I Regulatory Considerations and In-Silico Exploration of Cetilistat in The Treatment Of Non-Alcoholic Fatty Liver Disease Part II Preparation and Documentation of Device Master File"
‌: Vasekar Amey

"Part I - Regulatory Aspects for Zygomatic Implants as Medical Devices in India Part II - Internship at Meril Life Sciences Pvt. Ltd & IPCA Laboratories Ltd"
‌: Mistry Yukta

Part I Regulatory Scenario Of 3D Bioprinting In Developed And Developing Countries. Part II Exploring the Frontiers of Clinical Research: Insights at a Contract Research Organization
‌: Desai Rutuja

"Part I Regulatory Analysis and Comparison of Medical Device Recall In India, US and Europe: Understanding Causes and Consequences. Part II Dossier Preparation and Submission for US Market in Sun Pharmaceutical Industries"
‌: Bodke Samruddhi

"Part I Exploring The Regulatory Dynamics Of Artificial Intelligence (AI) and Machine Learning(ML) Based Smart Devices Part II Navigating Though the Reglatory Compliances at Glaxosmithkline Pharmaceuticals Limited for Clinical Trials in India"
‌: Mourya Aman

"Part I Financial Implications of Non-Compliance with U.S. F.D.A. Regulations on CGMP for Finished Pharmaceutical Products: A Case Study Analysis Part II Exploring the U.S.F.D.A. Regulatory Pathways"
‌: Shetty Samiksha

"Part I - Regulatory Framework for the Novel Polymers and Features of Approved Polymers in Orally Disintegrating Tablets as per U.S. FDA Part II - Preparation of Module 3 for the Submission of ANDA in the U.S. Market at Bliss GVS Pharma Ltd"
‌: Shetty Kavyashree

Part I Regulatory Considerations and Comparison of Drug Product Recall For Nitrosamine Impurity In India, USA And Europe Part II Navigating Regulatory Framework: A Strategic Approach in Industry"
‌: Mutalik Rucha

Part I Analysing Regulatory Pathways and Approval Processes for Spinal Orthopedic Implants: A Comparative Study of USA, EU And India Part II Preparing And Reviewing Dossier for Venezuela Country
‌: Pawar Himanshu

Textbook of drug design & discovery
‌: Larsen,Povl Krogsgaard
Հրապարակվել է: (2011)

Part I A Comparative Analysis of Medical Device Regulations in Emerging ASEAN Markets and India Part II Ensuring Compliance and Efficacy: A Statergic Approach to Executive Quality Assurance in Bioavailibilty and Bioequivalance Study
‌: Jadhav Archana

Drug Regulatory Affairs
‌: Singh, Gajendra
Հրապարակվել է: (2019)

Ancestral Affairs
‌: Daruwalla, Keki N
Հրապարակվել է: (2015)

Ancestral Affairs
‌: Daruwalla, Keki N
Հրապարակվել է: (2015)

Pharmaceutical Regulatory Process,
‌: Berry I.R
Հրապարակվել է: (2025)