Dr. Balwant Salunke has over 15 years of experience in clinical research, regulatory affairs, and academics. He holds a Ph.D. in Pharmacology and has worked in various roles such as Manager of Regulatory Affairs, Senior Executive, and Lecturer. His expertise includes bioequivalence studies, clinical trials, ANDA submissions to US FDA, and regulatory writing. He has published 5 research papers as the first author and reviewed several international manuscripts.

1. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
Dr. Balwantrao Pratap Salunke
[M. Pharm, Ph.D. (Pharmacology)]
E-mail: balwantsalunke@yahoo.com
Mobile: 07738383501, 09967901821
Present Address: Flat No. 203, Ramshree Verma Complex, Palghar (W), Pin-401404.
Objectives: Interdisciplinary Research Scholar with Pharma start-up experience. Trained as a pharmacist,
with experience in pre-clinical/clinical, regulatory technical and academic section, I have a well-rounded
knowledge base and skill set. I am adept at problem solving, look forward to the unique challenges and
opportunities inherent in a new position in Pharmaceutical Industry/CRO, first in the area of Clinical
Research or Regulatory Affairs.
Areas of Interest (willing to work)
Clinical/Medical Services, Regulatory Affairs, Academics.
Total Industrial Experience: More than 7 Years
Academic Experience: 1 academic year (Full Time Lecturer), 2 academic years (Contributory Lecturer)
Key Skills: Primary area of working is Bio-equivalence/Phase II/III clinical and animal studies.
Possesses experience in Clinical/Regulatory Affairs (CDSCO and USFDA).
Regulatory Writing: Protocols and protocol amendments. Informed Consent Forms/Patient
Information Leaflet. Clinical study reports, Investigator Brochure, Clinical sections of
common technical documents (CTDs), Literature summaries, Module 2 summary documents.
Medical Communication: Manuscripts, Abstracts, Journal articles, Posters, Slide
presentations.
• Clinical Monitor, Project/Study Co-ordination (Bioequivalence studies)
• Compilation, Review and Submission of ANDA for USA market (Module 1, 2, 3 & 5)
• Drafting of Query Response of ANDA for USA market
• Review of R&D, Manufacturing/QA/QC documents
• Involved in application procedure to DCG (I) to obtain BA/BE, and T-license permission
(TL and BENOC)
• Medical and/or Scientific Writing: Protocol and Report writing and, review of Clinical
Studies for different dosage forms (e.g. Tablets, Capsules, Granules, Patches, Creams, Gels,
and Foams etc.)
• Designing as well as review of subject CRFs
• Feasibility Studies of different dosage forms (e.g. Antihypertensive agents, Steroids,
Anticancer drugs, Vitamins, Antihyperlipidemic agents, Antipsychotics etc.)
• Designing of BA/BE studies with pharmacokinetic and clinical end points
• Knowledge on skin blanching protocols (by using chroma-meter)
• Designing of safety and efficacy studies and, Investigator’s Broucher
• Heading Regulatory Affairs Department-ROW market
Personal Skills
• High levels of resourcefulness, tenacity, autonomy, power, and self-possession
• Ability to work in competition and, as a team on multifaceted troubles
• Polished and professional presentation skill
• Familiarity with ICH, GMP, GLP, GCP and regulatory guidelines
Computer Proficiency
• Qualified MS-CIT with 66% (September 2003, MSBTE, Mumbai)
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2. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
• Working knowledge of Microsoft Windows, and Internet Surfing
• In addition, having sufficient knowledge of computer hard-ware
Software Skills
• Microsoft Windows XP/7/2000/98, Microsoft Windows Vista and Office 2003/07
• Graphpad Prism 4.0 and Instat 3.0, Volunteer DATABASE
• Chromatography Work Station (CSW), End Note
• Pharma Ready, ESG gateway for USFDA submissions.
Academic Qualifications
Sr.
No.
Degree Department/ University
Marks/
Percentage
Year of Passing
Class
Obtained
1
Ph. D.
(Faculty of
Medicine)
Dept. of Pharm. Sciences.
R.T.M. Nagpur University, Nagpur
Notification
July 24, 2014
Convocation
September 26,
2014
Degree
awarded
2
M. Pharm.
(Pharmacology)
Dept. of Pharm. Sciences.
R.T.M. Nagpur University, Nagpur
75.00
6 Dec. 2006
Degree-29/12/2007
Ist
with Distn
3 B. Pharm
Smt. S. S. Patil College of Pharmacy,
Chopda., Dist-Jalgaon. N.M.U. Jalgaon
63.28
14 June 2003
Degree-12/04/2004
I
4 D. Pharm
Smt. S. S. Patil Institute of Pharmacy.
Chopda. Dist-Jalgaon
(MSBTE. Mumbai)
67.50
28 June 2000
Degree-23/01/2001
I
5 H.S.C.
A. S & C College Chopda
Dist-Jalgaon
Divisional Board- Nasik (State Board-Pune)
54.17 7 June 1997 II
6 S.S.C.
L. M. Patil High School, Rajore
Dist. – Jalgaon
State Board-Pune
74.14 30 June 1995 I
Achievements: Academic Awards and Fellowships
• Qualified Graduate Pharmacy Aptitude Test (GPAT-2012) with 16.44%
• Qualified Graduate Pharmacy Aptitude Test (GPAT-11) with 10.22%
• Qualified Graduate Aptitude Test in Engg. (GATE-08) with 71.99 percentile
• Qualified Graduate Aptitude Test in Engg. (GATE-04) with 82.37 percentile
• Stand University third with distinction (75%)-Masters Programme (Pharmacology),
Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, 2006.
• UGC Fellowship for GATE Qualified Students, 2004-2006 (for Post Graduate studies).
• Awarded JRF in the scheme of Rajiv Gandhi National Fellowship (UGC Fellowship), 2009-
2011 (for Doctoral studies).
Professional Experience
[Note: The break in the service is because of pursuing of full time regular Ph.D. and for thesis submission
(Kindly consider)].
Sr.
No.
Organization Position Held
Month/Year of
Joining
Month/Year of
Leaving
Period of
experience
1
VHB Medi Sciences Limited Manager-Regulatory
Affairs
1st
July 2016 working -
2
Sidmak Laboratories (India) Pvt.
Ltd.
Sr. Executive-
Regulatory Affairs
15th
Oct 2013 13th
June 2016 2.8 years
3 Raptim Research Limited Executive -Technical 12th
March 2012 02nd
March 2013 1.0 year
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3. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
Documentation
4
Macleods Pharmaceuticals
Limited
Sr. Executive (CRA) -
Clinical section
14 June 2006 16 October 2009 3.4 years
5
Institute of Pharmacy
Chalisgaon, Dist-Jalgaon
Lecturer August 2003 May 2004
One academic
year
6
Dept. of Pharm. Sci. RTM.
Nagpur University Campus,
Nagpur
Contributory Lecturer Nov 2009 February 2012 2.3 years
Present Organization
1.VHB MEDI SCIENCES LIMITED
50-AB, Govt. Industrial Estate, Charkop Naka, Kandivali- West, Mumbai-400067
Area of working: Regulatory Affairs-ROW market
Job Profile: Manager-Regulatory Affairs
Experience: (Since 1st
July 2016)
Job Profile: To provide guidance on regulatory aspects to the team members. Final review of dossiers of
drug product. Drafting of query responses. To take care of bioavailability and bioequivalence requirement
on Sponsor’s behalf. Review of bio-study protocols, ICFs, agreements, IBs etc., as required. To manage all
the regulatory related activities including pharmacovigilance requirement in the department.
Previous Industrial Experience
2.Sidmak Laboratories (India) Pvt. Ltd (US FDA Approved)
302, Western Edge II, Opp. W.E. H., Magathane, Borivali (East) - 400 066
Designation: Sr. Executive-Regulatory Affairs
Experience (yrs): 2.8 (15th
October 2013 to 13th
June 2016)
Area of working: Bioequivalence and Regulatory Affairs
Primary area of working is clinical research. Second capability is in the Regulatory submissions.
To review R&D, manufacturing/QA/QC documents as required.
To review investigator’s broucher, study protocols, informed consent forms and clinical study reports.
To review study CRF’s. Monitoring of BA/BE studies.
USA Market: Involved in compilation, review and submission of ANDA (Generics).
Job Profile: Monitoring of bioavailability and bioequivalence studies on Sponsor’s behalf.
Review of bio-study protocols, ICFs, agreements, IBs etc., as required.
Compilation and Review of dossiers of drug product (ANDA, Module 1, 2, 3 & 5) in eCTD format for
submission. Contribute during ANDA submission procedure to regulatory agency by using Pharma-Ready
Software. Review of R&D and manufacturing documents/records but not limited to PDR, QOS, pack
inserts/PILS, BMR/BPR/stability protocols, validation protocols/reports etc. To prepare and review of
ANDA Amendment(s), query response and, its submission to Regulatory Agency.
3.Raptim Research Limited (CRO) (US FDA Approved)
A-226, TTC Industrial Area, Mahape MIDC, Navi Mumbai 400 710, India
Designation: Executive -Technical Documentation
Experience (yrs): 1 (12th
March 2012 to 02nd
March 2013)
Area of working: BA/BE Studies, Phase II & III Clinical Trials.
In addition, compilation of data (Module 5) in eCTD format for USA submission.
Job Profile: To perform feasibility studies of different dosage form for the Clients.
To write & to review study protocols, informed consent forms and clinical study reports.
To design as well as review of study CRF’s.
To design Investigator’s Broucher (IB).
To write, review and revise clinical SOPs.
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4. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
To make TL applications for the import of IPs and BENOC applications for granting approvals from DCG
(I) to conduct BA/BE studies.
4.Macleods Pharmaceuticals Limited, R&D, Andheri, Mumbai. (US FDA Approved)
Bioequivalence Department, Shantinagar, Andheri, Mumbai-93
Designation: Sr. Executive (CRA) - Clinical section
Experience (yrs): 3.4 (from 14 June 2006 to 16 October 2009)
Area of working: BA/BE Studies (Bioavailability and Bioequivalence in Humans)
Job Profile: To assist Clinical Section Head and Principal Investigator during BA/BE studies
To act as co-ordinator for conducting biostudies (handled more than 100 BA/BE studies as a project co-
ordinator. e.g. antiretrovirals, antihypertensives, antipychotics, antimalarials, antibiotics, antacids, drugs
acting on blood system, antituberculars etc).
To write study protocols, informed consent forms and clinical reports
To make overall co-ordination of all Clinical Research Associates (CRA)
To take care of pharmacy (investigational drug product accounting, dispensing and archiving)
To take care of volunteer databank
Audit faced: Successfully faced-DCGI, WHO, US FDA, ANVISA, ISO 9001
Academic Experience
• Teaching Experience (Lecturer) at Institute of Pharmacy Chalisgaon, Dist-Jalgaon
(August 2003- May 2004).
• Contributory Lecturer at Dept. of Pharm. Sci. RTM. Nagpur University Campus, Nagpur
(Nov 2009 to February 2012).
Industrial Training: Vital Healthcare Pvt. Ltd. Satpur, Nasik. (01/06/2003-30/06/2003)
Professional Enrollments
• Registered as a Pharmacist in Maharashtra State Council under Pharmacy Act 1948 (54960)
• Life member of Indian Pharmacological Society, India (LS683)
• Life member of Society of Biological Chemists, India (2620)
• Life member of Indian Pharmacy Graduates’ Association (LM5280)
• Life member of Society for Neurochemistry, India (LM-I-354)
Ph.D. Research Work
Title: Studies on the Neurohumoral Basis for the Behavioral Changes in Rodent on Exposure to
Electromagnetic Field. Supervisor: Prof. S. N. Umathe Co-Supervisor: Prof. J. G. Chavan
M-Pharm Research Work
Title: Influence of Oxidative Stress on the Drug Transport Mechanisms in Rat Intestine
Supervisor: Dr. S. N. Umathe
Instruments Handled
Refrigerated centrifuge, humidity/stability chamber, HPLC (Shimadzu 10 ATvp-), UV-spectrophotometer
(Shimadzu)-1601, 2401, plethysmo-meter (UGO Basile), shuttle box, elevated plus maze with video
tracking, anxiometer, convulseometer, marble burying behavior, open field test apparatus, forced
swimming test, stereotaxy (icv administration in brain). Electromagnetic field: Helmholtz coil system,
mobile phone frequency, microwaves.
Research Techniques Known
Possess sound knowledge on Behavioral Pharmacology. Oxidative Stress Parameters: catalase, superoxide
dismutase, reduced glutathione, lipid peroxidation, and protein carbonyl content.
Anti-inflammatory: Paw edema (carrageenan model).
Analgesic Model: Writhing reflex, hot plate method.
Transport studies: Everted intestine with perfusion apparatus.
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5. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
Publications as first author: Total 5 (National and International)
1. Balwant P. Salunke*, Sudhir N. Umathe, Jagatpalsingh G. Chavan. Effect of Electromagnetic
Radiations on Anxiety Related Behavior: A Review. Journal of Biomedical and Pharmaceutical
Research 2 (1) 2013, 36-40. [SJIF 2012: 3.068]
2. Balwant P. Salunke*, Sudhir N. Umathe, Jagatpalsingh G. Chavan. Low Frequency Magnetic Field
Induces Depression By Rising Nitric Oxide Levels In The Mouse Brain. International Journal of
Research and Development in Pharmacy and Life Sciences (IJRDPL). April -May, 2013, Vol. 2,
No.3, pp 439-450. [SJIF 2012: 3.027]
3. Salunke BP, Umathe SN, Chavan JG. Involvement of NMDA receptor in low-frequency magnetic
field-induced anxiety in mice. Electromagn Biol Med. 2014 Dec;33(4):312-26. [Impact factor:
1.000 ]
4. Salunke BP, Umathe SN, Chavan JG. Experimental evidence for involvement of nitric oxide in
low frequency magnetic field induced obsessive compulsive disorder-like behavior. Pharmacol
Biochem Behav. 2014 Jul;122:273-8. [Impact factor: 2.820]
5. Salunke BP, Umathe SN, Chavan JG. Behavioral in-effectiveness of high frequency
electromagnetic field in mice. Physiol Behav. 2015 Mar 1;140:32-7. [Impact factor: 3.033]
As a Reviewer: Reviewed few international manuscripts.
(Bioelectromagnetics, Conference paper-EICE-2014, Issues in Biological Sciences and Pharmaceutical
Research, Journal of Intercultural Ethnopharmacology etc.)
Scientific Presentations: Total 19 (National and International)
Extracurricular Activities
• Attended 54th Indian Pharmaceutical Conference, Dec. 2002. Pune.
• Attended 10th Association of Pharmaceutical Teachers of India, Oct. 2005 Nagpur.
• Attended 57th Indian Pharmaceutical Congress, 2005. Hyderabad.
• Attended International conference on Antioxidants and Free Radicals in Health-Nutrition
and Radio-protectors and V Annual Conference of the Society for Free Radical Research in
India (SFRR), Jan 2006. Kolkata.
• Attended one day training of Intellectual Property Rights, Nagpur.
• Attended 58th Indian Pharmaceutical Conference, Dec. 2006. Mumbai.
• Attended ‘Psycho-Oncology National Conference’ Nov 2010. Nagpur.
• Completed ‘Certificate course on Biophysics’ conducted by Dept. of Physics, Dr. Ambedkar
College, Nov 2010. Nagpur.
Personal Details
Date of Birth: 10th
March 1980 Marital Status: Married Languages Known: English, Marathi, and
Hindi
Nationality: Indian, Domiciled in Maharashtra State
Permanent Address: Gautam Nagar, Near SBI, Chopda, At. Post .Tal- Chopda, Dist-Jalgaon, Pin-425 107
(Maharashtra), India.
References
Prof. S. N. Umathe
M-Pharm. Ph.D.
Ex. Professor & Head
Department of Pharmaceutical Sciences,
Dr. Ashish Mungantiwar
M. Pharma. Ph.D.
President- Macleods Pharmaceuticals Limited,
R&D, Andheri, Mumbai
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6. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
RTM Nagpur University, Nagpur-440 033
Mobile No. 09373102858
Mobile No. 09867023914
Declaration: I hereby declare that the information furnished above is true and no related information is concealed. If any
discrepancy is observed at any stage, the authority is free to cancel my candidature.
Dr. Balwantrao
Salunke
Page 6 of 6

7. Resume of Dr. Balwant Salunke [M. Pharm., Ph.D (Pharmacology)]
RTM Nagpur University, Nagpur-440 033
Mobile No. 09373102858
Mobile No. 09867023914
Declaration: I hereby declare that the information furnished above is true and no related information is concealed. If any
discrepancy is observed at any stage, the authority is free to cancel my candidature.
Dr. Balwantrao
Salunke
Page 6 of 6