1. CURRICULUM VITAE
Mr. SAURABH A. PATHAK
Permanent Address:
A/228, Krishnakunj Society,
New V.I.P. Road,
Vadodara – 390 022
Tel: 9727742030
E-mail: saurabh9727742030@gmail.com
Qualification:
Master of Pharmacy (Pharmacology), from Pacific Academy of Higher Education &
Research Society, Udaipur, Rajasthan.
Bachelor of Pharmacy, NGSM Institute of Pharmaceutical Sciences, Mangalore, from
Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka.
Professional Experience:
11 years at Bioequivalence Department of Alembic Research Centre, Alembic
Pharmaceuticals Ltd, Vadodara, Gujarat. (Since November 2004 till date)
Current Designation:
Group Leader (Manager) – Clinical division
Skills:
 Project management
• Study feasibility assessment after coordination with cross functional teams,
project slotting and planning, coordination with Regulatory, Investigator/s,
Bioanalytical, QA personnel and other departments for study updates, report
submission on time, Coordination with sponsor/ monitors during their visits
 IMP handling
• Investigational product receipt, accountability, storage, dispensing and
retention as per regulatory requirements
 Regulatory compliance
• Preparation/ Review of Module 5 as per regulatory requirements (USFDA, EU,
ANVISA, MCC, TGA, Health Canada)
• Preparation of clinical and non-clinical overview as per medical expert
comments
• Regulatory query response
 Medical writing
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2. CURRICULUM VITAE
• Clinical study protocol preparation/ review as per regulatory requirements
(USFDA, EU, ANVISA, MCC, Health Canada, TGA, MoH Turkey, etc.), Informed
Consent Document preparation/ review
• Compilation and Application to DCG(I) for BE NOC and Test License
• Application of amendments
 SAE reporting
• Serious Adverse Event reporting to DCG(I) as per regulatory requirements and
timelines
• Detailed evaluation report submission to DCG(I)
 Clinical study monitoring
• Monitoring of in-house and outsourced studies
• Site selection visits, site initiation visits, site monitoring visits and site close out
visits for outsourced studies
• Retrospective audit of outsourced study data and clinical study reports
• Maintenance of Trial Master Files documents as per regulatory requirements
• Study monitoring visit at different CROs like Lambda, Axis Clinicals, QPS
Bioserve, MTR, etc.
 Quality Control & Training
• Motivation and training to clinical research associates
• Problem solving and guide CRAs for CAPA of any queries
• Risk assessment and Route cause analysis
• Implementation of risk mitigation strategies
 Regulatory inspections
• Preparation of facility/ system for regulatory inspection
• Compliance of facility/ system for regulatory inspection and gap analysis
• One of the first line member to face regulatory inspectors
Research Experience:
 Current designation: Group Leader (Manager-Clinical)
(From April 2015 till date)
• Handling and supervision of a team of 17 CRAs
• Sponsor coordination for studies/ IPs availability
• Study slotting according to requirements of project management and IPs
availability
• Coordination with Ethics committee for approval of study
protocols/amendments
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3. CURRICULUM VITAE
• Handling of medical writing team (preparation and review of protocols and
study reports)
• Compilation of Ethics committee approved protocols and other documents for
submission to DCG(I) for approval
• Supervision of Quality Control activities in clinical division
• Communication with QA/ Sponsor monitor for project related observations and
provide guidance to QC and CRAs for corrective actions of observations
• Coordination with Regulatory Department for regulatory queries
• Handling of Pharmacy team (IMP management)
• Preparation of facility/system for any regulatory audits
• Training of new and existing employees for system/ regulatory requirements
• Review of Electronic Common Technical Document (eCTD) report (Module 5)
before submission to RA
• Preparation/ Revision of Standard Operating Procedures as per requirements
 Previous designation:
Sr. Team Leader (Deputy Manager-Clinical) (July 2012 to March 2015)
Team Leader (Assistant Manager-Clinical) (July 2009 to June 2012)
• Handling and supervision of a team of CRAs
• Sponsor coordination for studies/ IPs availability
• Study slotting according to requirements of project management and IPs
availability
• Monitoring of outsource studies at CROs
• Coordination with Ethics committee for approval of study
protocols/amendments
• Compilation of Ethics committee approved protocols and other documents for
submission to DCG(I)
• Supervision of Quality Control activities
• Communication with QA/ Sponsor monitor for project related observations and
provide guidance to QC and CRAs for corrective actions of observations
• Coordination with Regulatory Department for regulatory queries
• Preparation of facility/system for any regulatory audits
• Training of new and existing employees for system/ regulatory requirements
• Review of Electronic Common Technical Document (eCTD) report (Module 5)
before submission to RA
• Preparation/ Revision of Standard Operating Procedures as per requirements
Research Scientist (Sr. Executive-Clinical) (April 2007 to June 2009)
• Preparation of Protocols and coordination with Ethics committee
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4. CURRICULUM VITAE
• Pharmacy Incharge
• Preparation of Report and Electronic Common Technical Document (eCTD)
report (Module 5)
• Study coordinator
• Perform and monitoring of clinical study activities as per Protocol
• Preparation of SOPs
Research Associate (Executive-Clinical) (Nov 2005 to April 2007)
Tr. Research Associate (Jr. Executive-Clinical) (Nov 2004 to Oct 2005)
• Study activities as delegated by Team Leader/ Principal Investigator
• Secondary Pharmacy In-charge
• Study coordinator
• Perform and monitoring of clinical study activities as per Protocol
Inspections faced:
• USFDA inspection (April 2010)
• ANVISA inspection (October 2011)
• Turkey MoH (December 2012)
• ANVISA inspection (December 2013)
• USFDA inspection (January 2015)
• Europe inspection by BfArM Germany and MPA, Sweden (February 2015)
• USFDA inspection (February-March 2015)
• MoH-Republic of Kazakhstan (March 2015)
• MoH-Tajikistan (May 2015)
• Drug Controller General of India (DCGI) inspection – 6 times (from 2010 to
2015)
Conference/Workshops/Trainings:
• “Certificate Program in Quality Assurance” by Prescription Pharma Support Pvt.
Ltd. (CPD Certification Service) (February to March 2013)
• Training on Good Clinical Practice (GCP) by STANDEV RESEARCH PVT. LTD.,
Mumbai (November 2012)
• Training on Good Clinical Practice (GCP) by ACEAS CLINICAL RESEARCH,
Ahmedabad (October 2011)
• Workshop on “Clinical Research – Advanced GCP and BA/BE Studies” by
Ethicare Clinical Research Services (ECRS) and K.B.Institute of Pharmaceutical
Education and Research (KBIPER), Gandhinagar (May 2009)
• Conference on Generation of “Electronic Common Technical type Document
(eCTD)” by Take Solutions (PharmaReady) at Mumbai (July 2008).
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5. CURRICULUM VITAE
• Training Program on “First Aid” by Rural Development Society, Panelav (March
2008).
• National workshop on “Good Clinical Practice for Pharmacologists” by Indian
Council of Medical Research (ICMR), New Delhi and Shri Sarvajanik Pharmacy
College, Mehsana (April 2007).
• Workshop on Clinical Trials Auditing at Site organized by PINNACLE HEALTH
CARE, Mumbai (February 2007).
• Conducted certificate training on “Good Clinical Practice” to Bioequivalence
department of BioArc Research Solutions (May 2007).
• Workshop on “Role and Responsibilities of IEC/IRB” conducted by Dr. Urmila
Thatte, Head – Clinical Pharmacology, TN Medical College and BLY Nair Hospital,
Mumbai (March 2006).
• Conference on Generation of “Electronic Common Technical type Document
(eCTD)” by Datapharm, USA at Vadodara (December 2005).
• Workshop on “Foundations of Clinical Research and Good Clinical Practice”
conducted by Dr. Arun Bhatt, ClinInvent Research Private Limited, Mumbai (May
2005).
Achievements:
• “Certificate of Achievement for outstanding contribution towards successful
ANVISA INSPECTION” presented by President-Technical Operations of Alembic
Pharmaceuticals Ltd. (April 2012)
• “Certificate of Achievement for outstanding contribution towards filling of
Alembic’s first FTF ANDA/ 505B2 application with USFDA” presented by Executive
Director of Alembic Pharmaceuticals Ltd. (March 2012)
• Certificate of “Appreciation/ Recognition for Excellent input on documentation
and Systems during ANVISA INSPECTION” presented by Vice President-Corporate
Quality & Regulatory Affairs of Alembic Pharmaceuticals Ltd. (October 2011)
Hands on computer:
• MS – Office
• WinNonlin
• Internet
Personal Information:
Name: Pathak Saurabh Ashishchandra
Date of Birth: 01st
June 1982
Marital Status: Married
Hobby: Listening music, Surfing
Saurabh Pathak
9727742030
Page 5 of 5

6. CURRICULUM VITAE
• Training Program on “First Aid” by Rural Development Society, Panelav (March
2008).
• National workshop on “Good Clinical Practice for Pharmacologists” by Indian
Council of Medical Research (ICMR), New Delhi and Shri Sarvajanik Pharmacy
College, Mehsana (April 2007).
• Workshop on Clinical Trials Auditing at Site organized by PINNACLE HEALTH
CARE, Mumbai (February 2007).
• Conducted certificate training on “Good Clinical Practice” to Bioequivalence
department of BioArc Research Solutions (May 2007).
• Workshop on “Role and Responsibilities of IEC/IRB” conducted by Dr. Urmila
Thatte, Head – Clinical Pharmacology, TN Medical College and BLY Nair Hospital,
Mumbai (March 2006).
• Conference on Generation of “Electronic Common Technical type Document
(eCTD)” by Datapharm, USA at Vadodara (December 2005).
• Workshop on “Foundations of Clinical Research and Good Clinical Practice”
conducted by Dr. Arun Bhatt, ClinInvent Research Private Limited, Mumbai (May
2005).
Achievements:
• “Certificate of Achievement for outstanding contribution towards successful
ANVISA INSPECTION” presented by President-Technical Operations of Alembic
Pharmaceuticals Ltd. (April 2012)
• “Certificate of Achievement for outstanding contribution towards filling of
Alembic’s first FTF ANDA/ 505B2 application with USFDA” presented by Executive
Director of Alembic Pharmaceuticals Ltd. (March 2012)
• Certificate of “Appreciation/ Recognition for Excellent input on documentation
and Systems during ANVISA INSPECTION” presented by Vice President-Corporate
Quality & Regulatory Affairs of Alembic Pharmaceuticals Ltd. (October 2011)
Hands on computer:
• MS – Office
• WinNonlin
• Internet
Personal Information:
Name: Pathak Saurabh Ashishchandra
Date of Birth: 01st
June 1982
Marital Status: Married
Hobby: Listening music, Surfing
Saurabh Pathak
9727742030
Page 5 of 5