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Assignment

The document lists various assignments related to pharmaceutical technology and regulatory affairs, detailing the titles and names of individuals assigned to each topic. Topics include the role of guidelines in drug manufacturing, challenges in scaling formulations, and regulatory requirements for drug approvals. Each entry highlights a specific area of focus within the pharmaceutical industry, emphasizing the importance of quality management and technology transfer.

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0% found this document useful (0 votes)
13 views4 pages

Assignment

The document lists various assignments related to pharmaceutical technology and regulatory affairs, detailing the titles and names of individuals assigned to each topic. Topics include the role of guidelines in drug manufacturing, challenges in scaling formulations, and regulatory requirements for drug approvals. Each entry highlights a specific area of focus within the pharmaceutical industry, emphasizing the importance of quality management and technology transfer.

Uploaded by

ramanatul837
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

SL NAME TITLE OF ASSIGNMENT REMARKS

N
O
1 AARUSHI KUKRETI  Role of SUPAC Guidelines in Streamlining Generic Drug Manufacturing in 2025

2 AKANKSHA BISWAS  Impact of Quality by Design (QbD) on Modern Pharmaceutical Development

3 ALFIYA MUSTAFA  Challenges in Scaling Up Liquid Oral Formulations for Global Markets

4 ANJANA SINGH  Technology Transfer Protocols for mRNA Vaccine Production

5 AYUSHI TYAGI  Regulatory Challenges in Approving Biosimilars in India

6 DIKSHA SHAH  Importance of Confidentiality Agreements in Technology Transfer

7 ISHA KAPOOR  Application of Six Sigma in Reducing Pharmaceutical Manufacturing Errors

8 KAVITA KUMARI  Space Requirements for Pilot Plants in Biologics Production

9 KOMAL TIWARI  WHO Guidelines for Technology Transfer in Low-Resource Settings

10 KUMARI SARITA  Role of CDSCO in Regulating New Drug Approvals in India

11 MANSI JAKHMOLA  Quality Risk Management in Pharmaceutical Technology Transfer

12 MEENAKSHI NEGI  Impact of ISO 9000 Standards on Pharmaceutical Quality Systems

13 MONIKA  Challenges in Analytical Method Transfer for Generic Drugs

14 MUSKAN SINGH  Significance of Investigator’s Brochure in Clinical Trials

15 NANDITA KUMARI  Scaling Up Solid Dosage Forms: Current Industry Trends

16 NISHA KUMARI  Role of NRDC in Facilitating Technology Transfer in India

17 PREETI RAWAT
 Regulatory Requirements for mRNA-Based Therapeutics in 2025
 Application of Platform Technology in Vaccine Development
18 PREMA RANA  Importance of GLP in Ensuring Pharmaceutical Product Safety

19 TANUJA KARAKOTI  Challenges in Commercializing Biologics: Case Study Analysis

20 VANDANA BHARTI  Role of Biostatistics in Clinical Trial Data Analysis

21 ABHISHEK KUMAR  Impact of ISO 14000 on Sustainable Pharmaceutical Manufacturing

22 ABHISHEK RAI  Technology Transfer from R&D to Production: Case Studies

23 ACHIT KUMAR KANNOJIYA  Regulatory Affairs in Navigating Global Drug Approval Processes

24 ADITYA PRAKASH SINGH  Pilot Plant Considerations for Semi-Solid Formulations

25 AKASH MAURYA  Role of TIFAC in Supporting Pharma Innovation in India

26 AMIT KUMAR MAHATO  Managing Out of Specifications (OOS) in Drug Manufacturing

27 AMIT KUSHWAHA  Validation Challenges in Pharmaceutical Equipment Scale-Up

28 AMIT MEENA  Importance of MoUs in Technology Transfer Agreements

29 ASHUTOSH SINGH  Role of BCIL in Promoting Biotech Technology Transfer

30 ATUL KUMAR RAMAN  Regulatory Strategies for Expedited Drug Approvals in Emergencies

31 AYUSH RAJ  Impact of Change Control on Pharmaceutical Quality Systems

32 BITTU  Pilot Plant Raw Material Challenges in Biosimilar Production


33 CHANDAN KUMAR SINGH  Role of Regulatory Affairs Professionals in Drug Development

34 HARISH MEENA  Technology Transfer for API Production: Current Challenges

35 KAMAL PANDEY  Significance of NABL Accreditation in Quality Testing Labs

36 LIYAKAT ALI  Clinical Research Protocols for Rare Disease Treatments

37 LOKESH KUMAR  Scaling Up Biopharmaceuticals: Personnel Training Needs


38 MANAS KUMAR  Role of SIDBI in Supporting Pharma Technology Transfer

39 MANISH MANIKPURI  Quality Control in Technology Transfer for Packaging Materials

40 OM JEET  Regulatory Requirements for Non-Clinical Drug Development


41 OM KUMAR  Impact of Total Quality Management on Drug Safety

42 PAPPU YADAV  Challenges in Data Presentation for FDA Submissions

43 PREET ANAND  Legal Issues in Pharmaceutical Technology Transfer

44 PRIYANSHU KUMAR MAHUR  Role of APCTD in Facilitating Technology Transfer in India

45 ROHIT KUMAR  Pilot Plant Documentation for Regulatory Compliance

46 RUDRAKSH  Application of Quality by Design in Continuous Manufacturing

47 SATYAM KUMAR  Role of State Licensing Authorities in Drug Regulation

48 SHIVAM GUPTA  Technology Transfer for Excipients: Industry Best Practices

49 SHUBHAM KUMAR  Managing Clinical Studies for New Drug Applications

50 SOHAM SADHUKHAN  Importance of Certificate of Pharmaceutical Product (COPP)

51 SUMIT KUMAR  Challenges in Scaling Up Topical Semi-Solid Formulations

52 TANISH BHARDWAJ  Role of Pharmacology in Non-Clinical Drug Development

53 VIDHANSHU PAINULY  Impact of Regulatory Authorities on Global Pharma Markets

54 VIJAY BHANDARI  Technology Transfer for Finished Pharmaceutical Products

55 VIVEK KUMAR YADAV  Six Sigma Applications in Reducing Batch Failures

56 ANUSHKA RAWAT  Historical Evolution of Regulatory Affairs in Pharma


57 KM HIMANI ARYA  Validation of Cleaning Processes in Technology Transfer

58 KHUSHBU KUMARI RAI  Role of Drug Metabolism Studies in New Drug Development

59  Challenges in Qualifying Pilot Plant Equipment


RENUPA KUMARI

60 ADARSH SHARMA  Regulatory Requirements for Conducting BE Studies in India

61 AJAY KUMAR  Impact of Quality Management Systems on Drug Recalls

62 CHANDRA BHAN SONKAR  Technology Transfer Documentation: Best Practices in 2025

63 CHETAN CHAMKANI  Role of TBSE in Supporting Pharma Startups in India

64 PRAVESH NEGI  Challenges in Managing Clinical Research Data

65 PRASHANT KUMAR Importance of ISO Standards in Pharmaceutical Quality Control


66 SHRUTI Pilot Plant Scale-Up for Continuous Manufacturing Processes
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