Dr. Jignesh Shah
(B.Pharm., M. Pharm., Ph.D)
Professor, Head of Department regulatory Affairs
Area of Interest
ü Pharmaceutical Regulatory affairs – dossier requirements (CTD, eCTD,), DMF, ASMF, SMF requirements, annual product quality review, Validation Documents Evaluation, PSUR, Dossier Module 4 and Module 5, BA/BE document requirements, PK endpoint study document requirements, NDA, ANDA, IND requirements.
ü Method Development, Analytical Method Validation , Dissolution AMV, Stability indicating studies, GMP Documentation and GLP.
ü Analytical Method Development using modern instruments like UV Spectrophotometer, HPLC, FTIR etc.
Majors Degrees
Ph. D. (Pharmacy) : June 2013
University : Bhagwant University, Ajmer, Rajasthan.
Specialization : Pharmacy (Pharmaceutical Analysis)
Title : Analytical Method Development and Stability indicating studies of Anticonvulsants.
M. Pharm. (Quality Assurance):
University : R. G. U. H. S. Bangalore, Karnataka.
Institute : National College of Pharmacy, Shimoga.
Class : Distinction (82.01%) Gold Medalist
Duration : 2007-2009
B. Pharm.:
University : R. G. U. H. S. Bangalore, Karnataka.
Institute : National College of Pharmacy, Shimoga.
Class : Distinction (78%)
Duration : 2002 - 2006
Online Certified Courses
Professional Experience
ü Total Experience 14 years
ü Currently working as a Professor & HOD at L. J. Institute of Pharmacy, Ahmedabad since 18th march 2013 in Quality Assurance and Regulatory Affairs Department.
ü Senior Executive, International Business Development, CBCC Global Research, Ahmedabad (08/2015 to 05/2017).
ü As Assistant Professor at S. J. Thakkar Pharmacy College, Rajkot from November 2009 to March 2013. (3.5 yrs)
ü As Lecturer at Veerayatan Institute of Pharmacy, Mandvi. Duration (0.6 yrs)
ü 3 month training at Sparsh Biotech Pvt. Ltd., Jamnagar, during B. Pharm.
Research Papers Citation
1. Jignesh S. Shah, Satishkumar A. Shetty, Manzoor Ahmed, B. K. Sridhar and Dharmesh J. Jani., (2010), Simultaneous spectrophotometric estimation of nebivolol hydrochloride and hydrochlorothiazide in combined tablet dosage form by area under curve method, Int. J. Chem. Sci., 8(1), 109-118.
2. Dharmesh J. Jani, Satishkumar A. Shetty, Manzoor Ahmed, B. K. Sridhar and Jignesh S. Shah., (2010), Simultaneous spectrophotometric estimation of atorvastatin calcium and amlodipine besylate in combined tablet dosage form by first order derivative method method, Int. J. Chem. Sci., 8(1), 306-314.
3. Dharmesh J. Jani, Satishkumar A. Shetty, Manzoor Ahmed, B. K. Sridhar and Jignesh S. Shah., (2010), Simultaneous spectrophotometric estimation of atorvastatin calcium and amlodipine besylate in combined tablet dosage form by area under curve method, Int. J. Chem. Sci., 8(1), 701-710.
4. Barot Hitesh., Vidyasagar Gali, Bhavin Sutariya and Jignesh Shah, (2010), Synthesis of Thiophene Compounds of Pharmacological Interest, Asian Journal of Research in Chemistry, 3(2), 1065-1068.
5. Bhalodiya H. A., Boda J. M., Shah J. S., Patel P. B., Vaghela J. P, (2011), The common technical document: Taking Indian NDA process towards globalization., International Journal of Pharmaceutical Sciences Review and Research, 9(2), 181-187.
6. Jignesh S Shah, G Vidyasagar, H Barot, (2012), Simultaneous RP-HPLC method for estimation of zonisamide and lamotrigine in combined dosage form and in spiked human plasma, Inventi Impact: Pharm Analysis & Quality Assurance , 12(3), 169-176.
7. Jignesh S Shah, G Vidyasagar, H Barot, (2012), Sensitive spectrofluorimetric method of analysis for pregablin in spiked human plasma and formulations, Inventi Impact: Pharm Analysis & Quality Assurance , 12(2), 86.
8. Jignesh S. Shah*, G. Vidyasagar and H. Barot., (2012), Stability indicating RP-HPLC method for estimation of levetiracetam in pharmaceutical formulation and application to pharmacokinetic study, Der Pharmacia Sinica, 3(5), 576-589.
9. N M Jagani, V D Prajapati, J S Shah and P B Patel., (2012), Quantitative estimation of cinitapride in tablet formulation by zero & first order derivative spectrophotometry using area under curve method, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 285.
10. N M Jagani, J S Shah, M M Sorathiya, J P Vaghela and P B Patel, (2012), Spectrophotometric simultaneous estimation of cinitapride and omeprazole by ratio derivative and area under curve method, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 339.
11. Nayan M Jagani, Jignesh S Shah and Parula B. Patel., (2012), Development and validation of dual wavelength method for simultaneous estimation of omeprazole and cinitapride in combined capsule dosage form, International Journal of Research in Pharmaceutical and Biomedical Sciences, 3 (2), 762-67.
12. N M Jagani, J S Shah and P B Patel., (2012) Development and validation of spectroscopic method for simultaneous estimation of omeprazole and cinitapride hydrogen tartrate in combined dosage form, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 272.
13. Jagani N. M., Prajapati V. D., Shah J. S., Patel P. B, (2012), Development and validation of Reverse Phase High Performance Liquid Chromatography Method for simultaneous estimation of cinitapride and omeprazole in combined capsule dosage form, Int. J. Pharm. Sci. Rev. Res., 15(2), 35-41.
14. Patel H. A., Vaghela J. P., Shah J. S., Patel P. B, (2012), Development and validation of RP-HPLC Method for estimation of cefpodoxime and dicloxacillin in combined dosage form and its application in dissolution study, Int. J. Pharm. Sci. Rev. Res., 15(2), 50-56.
15. Y R Sankharva, J S Shah and P B Patel., (2012) Development and validation of simultaneous equation method for the estimation of cefpodoxime and ofloxacin in combined tablet dosage form, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 288.
16. Y R Sankharva, J S Shah and P B Patel., (2012) Development and validation of RP-HPLC method for the estimation of cefpodoxime and ofloxacin in combined tablet dosage form, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 394.
17. V D Prajapati, J S Shah and P B Patel., (2012) Simultaneous estimation of citicoline and piracetam by uv spectrophotometric method in combined solid dosage form, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 314.
18. V D Prajapati, J S Shah and P B Patel., (2012) Simultaneous estimation of citicoline and piracetam by RP-HPLC method in combined solid dosage form, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 427.
19. C R Sharma, J Akhtar, N M Jagani, Y R Shankharva and J S Shah ., (2012), UV spectrophotometric method for estimation of Silodosin from its solid dosage form , Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 310.
20. Riddhi S Chavda, Jagruti P Vaghela, Parula B Patel, Jignesh S Shah., (2012), UV spectrophotometic methods for simultaneous estimation of Montelukast sodium and Desloratadine in combined tablet dosage form , Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 416.
21. Makwana K K, Bhatt U K, Patel P B, Shah J S., (2013), Simultaneous spectrophotometric estimation of Levosulpiride and Pantoprazole by zero order, area under curve and dual wavelength method, Inventi Rapid: Pharm Ana & Qual Assur, 12(2), 566.
22. Vishal Prajapati, Dr. Jignesh Shah, Dr. Dilip Maheshwari., (2014), Comparative study of Good Manufacturing Practise (GMPs) requirements of sterile Pharmaceutical products in India and USA, Journal of Pharmaceutical Science and Bioscientific Research, 4(2), 150-155.
23. Dharmesh Zanzarukiya, Dr. Jignesh Shah., Development and validation of first order derivatie spectrophotometric method for simultaneous estimation of Theophylline and Bambuterolin bulk and synthetic mixture, Journal of Pharmaceutical Science and Bioscientific Research, 4(2), 139-144.
24. Parth Sonara, Dr. Jignesh Shah., Absorption correction method for simultaneous estimation of PhenazopyridineHCl and Ciprofloxacin HCl in combined tablet dosage form, Journal of Pharmaceutical Science and Bioscientific Research, 4(2), 172-176.
25. Ishan Sharma, Dr. Dilip Maheshwari, Dr. Jignesh Shah., Method development and Validation for simultaneous estimation of Aliskiren and and enalapril in bulk and synthetic mixture by Reverse phase High Performance liuqid chromatography, Pharmacophore, 5(2), 239-245.
26. Mehul Jakasaniya, Dr. Jignesh Shah, Dr. Dilip Maheshwari., Simultaneous estimation of Clobetasol Propionate and Fusidic acid in cream dosage form by Reverse phase High Performance liuqid chromatography, Pharmacophore, 5(2), 231-238.
27. Neha M, Jignesh S.S, Dilip G.M, Absorption Correction Method For Simultaneous Estimation Of Moxonidine And Amlodipine Besylate In Combined Pharmaceutical Formulation, International Journal of Pharmacy and Pharmaceutical Science, 6(6), 231-235.
28. Rathod D, Jignesh S.S, Dilip G.M, A study of variation in Pharmaceutical products in Phillipines and variation policies in Canada and Australia, Journal of global trends in pharmaceutical science, 6(1), 2340-2344.
29. Reddiar Janagi, Jignesh shah, Dilip Maheshwari, Scenario of Management of Medical Waste in US and UK: A review, Journal of global trends in pharmaceutical science, 6(1), 2328-2339.
30. Khushboo vora, Jignesh Shah, Dilip Maheshwari, Annual Product Quality review: Regulatory Aspect, Journal of global trends in pharmaceutical science, 6(1), 2345-2350.
31. Ketan Mishra, Jignesh Shah, Dilip Maheshwari, Current European Regulation Perspective on Pediatric Clinical Trials, Journal of global trends in pharmaceutical science, 6(1), 2311-2315.
32. Pooja D. Soneji, Dr. Jignesh S. Shah* and Dr. Dilip G. Maheswari, Development And Validation Of Analytical Method For Simultaneous Estimation Of Leflunomide And Methotrexate In Synthetic Mixture By Q-Absorbance Ratio Method, International Journal of Pharmacy and Technology, 6(4), 7500-7512.
33. Jignasha M. Jadav, Dr. Jignesh S. Shah* and Dr. Dilip G. Maheswari, Analytical Method Development & Validation For Simultaneous Estimation Of Propranolol & Prazosin In Synthetic Mixture, International Journal of Pharmacy and Technology, 6(4), 7553-7568.
34. Ruchi H.Majithia, Dr. Jignesh S. Shah* and Dr. Dilip G. Maheswari, Development and validation of analytical method for estimation of anagliptin in tablet dosage form by UV. Spectrophotometric method, International Journal of Pharmacy and Technology, 6(4), 7587-7599.
35. Dhara K. Dixit, Dr. Jignesh S. Shah* and Dr. Dilip G. Maheswari, Target Product Profile: An Essential Tool In Drug Development, International Journal of Pharmacy and Technology, 6(4), 7553-7568.
36. Dr. Jignesh S. Shah, Priti V. Patel and Dr. Dilip G. Maheshwari, Current Perspective On Solvent Free Analysis In Pharmaceutical Industry, World Journal of Pharmacy and Pharmaceutical Sciences, 4(4), 1770-80.
37. Khushboo Vora, Jignesh Shah, Dilip Maheshwari, Comparitive Evaluation Of Annual Product Quality Review With Respect To US And Europe, International Journal of Recent Scientific Research, 6(4), 3336-3341.
38. Rathod D, Jignesh S.S, Dilip G.M, Prerequsites for pharmaceutical variation in products for Philippines, International Journal of Institutional Pharmacy and Life Sciences, 5(2), 430.
39. Ketan M, Jignesh S.S, Dilip G.M, Harmonization and comparative Study of regulation on Pediatric drugs in US, UK and Tanzania, International Journal of Institutional Pharmacy and Life Sciences, 5(2), 411.
40. Ketan Mishra, Jignesh shah, Dilip Maheshwari, Current European Regulation Perspective on Pediatric Clinical Trials, Journal of global trends in pharmaceutical science, 6(1), 2311-2315, 2015.
41. Reddiar Janagi, Jignesh shah, Dilip Maheshwari, Scenario of Management of Medical Waste in US and UK: A review, Journal of global trends in pharmaceutical science, 6(1), 2328-2339, 2015.
42. Pooja D. Soneji, Dr. Jignesh S. Shah and Dr. Dilip G. Maheshwari, Development And Validation Of Analytical Method For Simultaneous Estimation Of Leflunomide And Methotrexate In Synthetic Mixture By Q-Absorbance Ratio Method, International Journal of Pharmacy and Technology, 6(4), 7500-7512, 2015.
43. Jignasha M. Jadav., Dr. Jignesh S. Shah and Dr. Dilip G. Maheshwari, Analytical Method Development & Validation For Simultaneous Estimation Of Propranolol & Prazosin In Synthetic Mixture, International Journal of Pharmacy and Technology, 6(4), 7581-7597, 2015.
44. Swathi M. Nambia, Dr.Jignesh S. Shah, Dr. Dilip G. Maheshawari, Market Analysis of Hormonal Products In Infertility, WJPPS, 4(11), 439-443, 2016.
45. Kinjal A. Patel, Dr. Jignesh S. Shah, Dr. Dilip G. Maheshwari, A Review On Analytical Methods For Determination Of Cephalosporins And Oxazolidinones Bulk And In Different Dosage Forms, WJPPS, 4(11), 528-536, 2016.
46. Zeel T. Doshi, Dr. Jignesh S. Shah, Dr. Dilip G. Maheshawari, Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Telmisartan And Nifedipine in Bulk and Synthetic Mixture, IJPT, 7(2), 9170-9177, 2016.
47. Vikas Kumar Vyas, Dr. Jignesh S. Shah, Dr. Dilip Maheshwari, Medicated Device Combination Product: An Overview, JGTPS, 6(3), 2777-2783, 2016.
48. Pankti M. Shah, Dr.Jignesh Shah, Dr. Dilip G. Maheshwari, Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Valsartan And Nifedipine in Bulk and Synthetic Mixture, IJPT, 7(2), 9161-9169, 2016.
49. Zinal Dushyantbhai Shah, Dr. Jignesh S. Shah, Dr. Dilip G. Maheshwari, A Review On Strategic Plan or Prevneting And Mitigating Drug Shortages In USA, WJPPS, 4(11), 620-631, 2016.
50. Zeel T. Doshi, Dr.Jignesh S. Shah, Dr. Dilip G. Maheshwari, A Review on Analytical method for determination of calcium Channel Blocker in different dosage form, JGTPS, 6(3), 2829-2839, 2016.
51. Pankti M. Shah, Dr.Jignesh Shah, Dr. Dilip G. Maheshwari, A review on Analytical methods for determination of Angiotensin 2 receptor in different dosage form, JGTPS, 6(3), 2805-2816, 2016.
52. Pankti M. Shah, Dr.Jignesh Shah, Dr. Dilip G. Maheshwari, Development & Validation of RP-HPLC method for simultaneous estimation of Valsartan & Nifedipine in synthetic mixture, AJPTI, 4(17), 42-56, 2016.
53. Kinjal A. Patel, Dr. Jignesh S. Shah and Dr. Dilip G. Maheshwari, Development And Validation Of First Order Derivative Spectrophotometric Method For Simultaneous Estimation Of Cefuroxime Axetil And Linezolid In Combined Dosage Form, IJPT, 8(1), 10336-10343, 2016.
54. Vishva S.Patel, Dr, Jignesh Shah, Effect of Recent Amendment in Drug & Cosmetic Act in India, AJPTI, 4(19), 2017.
55. Siddhi Shah, Dr. Jignesh Shah, Common Deficiencies Observed by Various Regulatory Agencies, AJPTI, 4(19), 2017.
56. Pragati Vanavi Dr. Jignesh Shah and Dr Dilip Maheshwari, Harmonization in microbial limit test of USP and EP, AJPTI, 4(19), 61-70, 2017.
57. Dr. Jignesh Shah, Jignasha Panchal, Monoclonal Antibodies Present New Opportunities in Disease Diagnosis and Treatment, AJPTI, 4(19), 2017.
58. Pragati Vanavi, Dr Dilip Maheshwari, Dr Jignesh Shah, A riview article on literature review of chromatographic, spectrophotometric and other methods for quantitative estimation of terazosin hydrochloride and tolterodine tartrate in pure and combination with other drugs, EJPMR, 4(1), 192-200, 2017.
59. Ripal Suthar, Jignesh S. Shah, Review on technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines, AJPTI, 5(23), 32-40, 2017.
60. Rimpalben Patel, Jignesh Shah, Dilip G Maheshwari, A review on chromatographic and spectrophotometric method for estimation of Aliskiren and losartan potassium in bulk and in different dosage forms, IJRPPS, 3(1), 2018, 109-118.
61. Nazneen Patel, Jignesh S Shah, Dilip Maheshwari, A review on chromatographic and spectrophotometric method for estimation of Sumatriptan and Promethazine in bulk and in different dosage forms, IJRPPS, 3(1), 2018, 144-153.
62. Binal J Parekh, Jignesh S Shah, Dilip G Maheshwari, A review on chromatographic and spectrophotometric method for estimation of Rosuvastatin calcium and Gemigliptin in synthetic mixture, IJRPPS, 3(1), 2018, 71-78.
63. Darshil B S, Bhavesh H. P, Jignesh S S, Development And Validation Of Analytical Method For Determination Of Celecoxib And Amlodipine Besylate In Pharmaceutical Formulation Using Design Of Experiment And Response Surface Methodology, International Journal of Life Science and Pharma Research (Accepted) March 2022.
65. Current trends in chromatographic prediction using artificial intelligence and machine learning. Published by - Analytical Methods, I.F. - 3.2
66. Quality by Design Based Development and Quantification of Telmisartan and Rosuvastatin Calcium Using RP-HPLC. Published by - Oriental Journal of Chemistry, I.F. - 0.5
67. Emerging trends in extraction and analytical techniques for bromelain. Published by - Journal of Liquid Chromatography & Related Technologies, I.F. - 1.4
68. Response surface methodology-based quantification of lamivudine and zidovudine using reverse-phase high-performance liquid chromatography in pharmaceutical formulation. Published by - Asian Journal of Pharmaceutical Research and Health Care
69. Exploring the Data Integrity Ordinance in Pharmaceutical Domain. Published by - Journal of Young Pharmacists
70. Response Surface Methodology Based Development and Quantification of Celecoxib and Amlodipine Using RP-HPLC. Published by - Int. J. Life Sci. Pharma Res.
Articles Published
- Jignesh Doshi, Bhushan Trivedi: A Quick Look at Data Redaction, Security, Computer Society of India (CSI) Communication, August 2016
- Jignesh Doshi, Bhushan Trivedi: Penetration testing - A Thirst for Web Application Security Risk Mitigation, Security, Computer Society of India (CSI) Communication, August 2015
- Jignesh Doshi, Bhushan Trivedi: A Quick Look at Virtual Private Database Security, Computer Society of India (CSI) Communication, November 2014, Page 36-37
Books
- GTU Paper Solution Pharmaceutical Analysis BP102TP; Nirav Prakashan; First Edition 2021
Awards & Achievements
ü Minor Research Project Grant Awarded from GUJCOST Rs:100000
ü AICTE Sponsored two weeks Staff Development Programme on “Patenting in Pharmaceuticals” organized by S. J. Thakkar Pharmacy College, Rajkot. 17th May to 29th May, 2010.
ü AICTE Sponsored National Seminar on “Recent Advances In Pharmaceutical Chemistry” held at L. J. Institute of Pharmacy, Ahmedabad. 24th and 25th January – 2014.
ü Gujcost Sponsored National Seminar on “Quality by Design: Recent Perspective on Process Development and Implementation” held at LJ. Institute of Pharmacy, Ahmedabad, 24th – 25th July – 2015.
ü Poster Presented at NIPiCON 2018, International Conference held at Nirma University, 23rd – 25th January - 2018
ü International Conference on Pharmaceutical Regulatory Affairs: Current Scenario & 1st National Convention of Indian Society of Pharmaceutical Regulatory Affairs – Organized by K. B. Institute of Pharmaceutical Education & Research, Gnadhinagar, held on 8th September 2018.
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Python 3.4.3 and Django by CMR college of engineering associated with spoken tutorial IIT Bombay from 8th June 2020 to 13th June 2020.
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Nano Technology in Water and Waste Water Treatment by Indian Water Works Association , ( IWWA ) Vadodara Centre on 20th May 2020
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Learning Pedagogy and effective use of Case methodology from 17th may to 21st may 2020 by ASMA, Pune
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Novel Approaches of Blockchain Technology & its Application from 22nd may 2020 to 28th May 2020 by Teerthankar Mahaveer University, Uttar Pradesh
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84th International conference & HR Congress – Employment scenario post Covid-19 by University of Engineering and Management May 23 2020
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Emerging research issues in Software and IT sector by CMR Engineering college on 18th May 2020
Subject Taught
Subjects taught : Undergraduates
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Regulatory Science (Semester 8)
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Instrumental Methods of Analysis (Semester 7)
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Quality Assurance (Semester 7)
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Pharmaceutical Analysis (Semester 1)
Regulatory Science (Semester 8)
Instrumental Methods of Analysis (Semester 7)
Quality Assurance (Semester 7)
Pharmaceutical Analysis (Semester 1)
Subjects taught : Postgraduates
- PG Projects
- Research Methodology and Biostatistics (Semester 3)
- Audits and Regulatory Compliance (QA Semester 2)
- Pharmaceutical Manufacturing Technology (QA Semester 2)
- Quality Management System (QA Sem 1)
- Product Development and Technology Transfer (QA Sem 1)
- Regulatory Aspects of Medical Devices (RA Semester 2)
- Regulatory Aspects of Food & Nutraceuticals (RA Semester 2)
- Regulatory Affairs Practical II (RA Semester 2)
- Clinical Research Regulations (RA Sem 1)
- Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights (RA Sem 1)
- Regulatory Affairs Practical I (RA Sem 1)
Seminars Conducted
|
Title
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Month & Year
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Venue
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| "Advanced Manufacturing of Biomedical Devices for Precision Health Technologies" |
24/01/2022 to 28/01/2022
|
Indian Institute of Technology Tirupati., AICTE Training And Learning (ATAL) Academy Online Advanced FDP
|
| "Pharmaceutical R & D Ecosystem: From Bench to Market" |
03/01/2022 to 07/01/2022
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GTU - GRADUATE SCHOOL OF PHARAMCY, AICTE Training And Learning (ATAL) Academy Online Advanced FDP
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| “RECENT ADVANCEMENT IN OCULAR DRUG DELIVERY SYSTEM” |
10/04/2021.
|
Shree H.N. Shukla Institute of Pharmaceutical Education & Research |
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HPTLC Method Development-,Trick or Treat? - Learn, Relax and Stress out- Tech Model.
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08/06/2021
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Shree Ramchandra institute of Higher education and Research, Chennai
|
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Application of LCMS in Bioanalysis
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08/04/2017
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Maharaja Sayajirao University of Baroda
|
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STI connect forum at University for R&D Proposals on state priority areas of S&T
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20/10/2020
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NIRMA UNIVERSITY
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Understanding what and how of Publishing ethics
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14/10/2020
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Springer Nature
|
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Innovative approaches in writing Good scientific paper
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30/06/2021
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Ganapat University
|
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“DRUG REPURPOSING (DR): AN EMERGING APPROACH IN DRUG DISCOVERY”
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14 - 19 June, 2021.
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Anand Pharmacy College, Anand
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| Awareness of Due Diligence & Know-Your-Customer Practices to Secure Biological Materials, Equipment, and Knowledge |
24-26 May, 2021
|
CRDF GLOBAL
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| ‘NAVIGATING YOUR JOURNEY FROM RESEARCH TO PATENT & HOW PATENT AND PUBLICATION DIFFER?' |
18/04/202
|
Society of Pharmaceutical Science and Research (SPSR) |
| ‘COUNTERING THE RISE OF SUPERBUGS THROUGH ANTI-MICROBIAL RESISTANCE' |
21/02/2021 | Society of Pharmaceutical Science and Research (SPSR) |
Professional Services
ü Pharmaceutical Regulatory affairs – dossier requirements (CTD, eCTD,), DMF, ASMF, SMF requirements, annual product quality review, Validation Documents ü Evaluation, PSUR, Dossier Module 4 and Module 5, BA/BE document requirements, PK endpoint study document requirements, NDA, ANDA, IND requirements.ü üMethod Development, Analytical Method Validation, Dissolution AMV, Stability indicating studies, GMP Documentation and GLP.
ü Analytical Method Development using modern instruments like UV Spectrophotometer, HPLC, FTIR etc.
Contact
LJ Institute of Pharmacy,
LJ Campus, Near Sarkhej-Sanand Circle,
Off. S.G. Road, Ahmedabad-382210
Phone: 7228982299
Email: jignesh.shah_ljip@ljinstitutes.edu.in