Atul Solankar

Clinical Research Professional with close to 23 years of experience in CROs and Pharmaceutical companies covering clinical and non-clinical studies for global regulatory submissions. 

Leading a team of GCP, GLP and total quality management system including auditing, ensuring quality and compliance as per respective regulatory requirements. 

Prepared all clinical, bio-analytical and statistical sites for global regulatory inspections viz., US FDA, EMA, UK MHRA, ANVISA-Brazil, WHO, NPRA-Malaysia, MOH-Turkey, DCGI etc. 

Lead successful multiple clinical, bio-analytical regulatory inspections (US FDA, EMA, ANVISA-Brazil and DCGI) and customer audits for multiple clinical studies for various regulatory submissions. Monitored and involved in conducting more than 2000 bioequivalence studies for various regulatory market. 

Successfully conducted numerous 505(b)(2) and NCE-1 as well as First-To-File (n=2) clinical studies for US FDA submission. 

Established harmonized systems across all centers which are in compliance and adherence to all required international quality standards. Handled more than 100 regulatory inspections from various international bodies like USFDA, EMA, ANVISA, WHO, MCC (South Africa) and many more.

Professional Experience

April 2022 – March-2023:                             President, Business Development, Project Management and Regulatory Affairs 

Accutest Research Laboratories Ltd., 

Responsibilities:

• Identifying project manager, planning and scheduling studies across Mumbai, Ahmedabad and Vadodara in coordination with clinical and bio-analytical team. 
• Project tracking using Project Management software developed in-house.
• Scheduling, conducting project review meeting and complying turnover from quarter to quarter. 
• Defining project scope in collaboration with client, setting timelines, analysing requirements, prioritizing tasks and ensuring timely execution; monitoring the entire execution of project including administrative activities like logistic across projects.
• Steering project activities and ensuring strategic utilization of available resources as per schedules; ensuring maintenances of financial (turnover) updating daily MIS for driving operational efficiency.
• Maximizing business opportunities and consistently working towards achieving sales targets; working with clients and industry partners on mutually beneficial growth opportunities and maintaining customer satisfactions by providing quality, cost effective and on timely delivery of project. 
  • Met business target on quarter to quarter in spite of challenges like covid-19 pandemic, 
• Developing strong knowledge of existing and potential clients building strong client relationships; performing market and competitor analysis by keeping information of trends and competitor moves to achieve market share. 
• Submission of regulatory applications for obtaining permissions to conduct BA/BE studies, facility applications (ANVISA, NPRA etc.) and participating in SEC meeting for obtaining permissions to conduct clinical trials in patients. 

Achievements:

• Won challenging projects (NCE-1) for US FDA submissions
• Gained sponsor confidence in executing multiples studies in stipulated time period to achieve regulatory submission timeline. 

September 2008 – March 2022:                   President, Regulatory Affairs and Quality Assurance 

Accutest Research Laboratories Ltd., 

Responsibilities:

• Facilitator to regulatory inspections e.g., US FDA, EMA, ANVISA, WHO, etc. and sponsor audits/monitoring visits. 
• Compliance to sponsor audit or regulatory inspections (e.g., FDA, EMA, ANVISA, WHO etc.) and query/deficiencies reply. 
• Review of CTD/e-CTD compilation and submission to various Regulatory authorities 
• Total Quality Management (Review of SOPs, tracking in-house system-based audits, in-process and facility-based audits, updating regulatory guidelines and training)  
• Planning, Scheduling, conducting audits of Clinical trials (Phase I-III) and BA/BE studies 
• Preparation and Submission of Clinical Trial Application with DCGI
• Preparation and review of Master (with Sponsor) and Research (with Investigator) Service Agreement as well Confidentiality Agreement. 
• Retrospective audit (Review) of Clinical Study Report, Method Validation Report, Bioanalytical report including incurred sample reanalysis data for adequacy as per applicable regulatory requirements e.g., US FDA, TPD, TGA, ANVISA, WHO, EMA, MCC, DCGI etc., 
• Preparation and updating of Regulatory application and approval process 
• Preparation and Review of Site Master File and Quality Manual

Achievements:

• Successfully faced US FDA, EMA, UK MHRA, WHO, NPRA and DCGI inspections and international sponsor audits.
• Successfully faced US FDA inspections for patient-based PK studies conducted at Investigational Site for therapeutic area of Oncology, Psychiatry etc.  
• Reviewed clinical study reports for more than 2000 bioequivalence studies. 

March 2008 – August 2008:                         General Manager, Quality Assurance Lambda Therapeutic Research,

          Ahmedabad 

Responsibilities:

• Compliance to sponsor audit or regulatory inspections (e.g., FDA, EMA, ANVISA, WHO etc.) and query/deficiencies reply.
• Review of CTD/e-CTD compilation and submission {Module 5 and partially Module 2 (2.7)}
• Total Quality Management (Review of SOPs, tracking in-house system-based audits, in-process and facility-based audits, updating regulatory guidelines and training)
• Feasibility checks and Review of clinical study protocols of Clinical trials/Bioequivalence trials as per regulatory requirements and compliance.  
• Preparation and review of Master (with Sponsor) and Research (with Investigator) Service Agreement as well Confidentiality Agreement. 
• Review of Clinical Study Report, Bioanalytical report including incurred stability Reproducibility data, Method Validation Report for adequacy to be submitted as part of ANDA of Drug Dossier as per applicable regulatory requirements.
• Preparation and updating of Regulatory application and approval process
• Preparation and Review of Site Master File and Quality manual 
• Overall co-ordination of Quality Assurance activities at Ahmedabad site
• To ensure effective implementation of Quality Systems
• Planning, Scheduling, conducting audits of Clinical trials (Phase I-III) and BA/BE studies
• Timely and effective conduct of internal audits (in-process, retrospective and system audits) at various departments to ensure that studies are conducted as per approved protocol, SOPs and applicable regulatory requirements.
• Coordinate sponsor visits/audits and regulatory inspections
• Review of standard operating procedures of all departments including QA department for correctness, adequacy and completeness.
• Compliance to query raised during sponsor audits, regulatory review or inspection.
• Review of clinical study protocols and reports for compliance to GCP/GLP and other applicable regulatory requirements. 
• Train auditors on principles of GCP/GLP and Quality Assurance aspects on continuous basis.

Achievements:

• Successfully faced ANVISA and DCGI inspections and international sponsor audits.
• Conducted retrospective audits (Phase II, III and BE) of clinical studies conducted at Investigational Site for therapeutic area of Oncology, Psychiatry and Osteoarthritis. 
• Reviewed clinical study reports for more than 50 bioequivalence studies. 

November 2006 – February 2008:               Head, Regulatory Affairs and Quality Compliance

Accutest Research Laboratories Ltd., 

Navi Mumbai

Responsibilities:

• Compliance to sponsor audit or regulatory inspections (e.g., FDA, AFSSAPS, MPA, CBG-MEB, ANVISA, WHO etc.) as well query reply.
• Reviewing method validation and bio-analytical reports for adherence to Good Laboratory Practices.
• Reviewing clinical study reports as per various regulatory guidelines. 
• Guiding team for e-CTD submission. 
  • Faced US FDA, ANVISA, Swedish Regulatory authority, WHO (three times) inspections and international sponsor audits.

Achievements:

• Reviewed clinical study reports for more than 150 bioequivalence studies. 
• Developed in-house system to represent clinical study report in Module 5 in compliance with eCTD requirement. 

October 2004 – October 2006:                    Research Scientist (» Manager)

                                                                        Corporate Quality Assurance

Ranbaxy Laboratories Ltd., 

Responsibilities:

• Ensuring Good Clinical Practices (GCP) compliance in the conduct of Clinical trials of NCEs/Generic drugs for quality and integrity of data.
• To schedule and conduct independent audits of clinical trials (Phase I, II and III) and bio-equivalence studies (ANDA - US/ANVISA submission and other regulatory authorities) to ensure GCP compliance.
• Ensuring Good Laboratory Practices compliance in the conduct of non-clinical studies of New Chemical Entities (NCEs) for regulatory submission.
• Reviewing bio-analytical method validation reports of NCEs/Generic drugs for adherence to Good Laboratory Practices.
• Reviewing study reports of New Chemical Entities for IND submission (including, Pre-formulation, Validation of Analytical methods, Product development, Safety pharmacology, Metabolism and Toxicology).
  • Reporting audit findings to the Principal Investigator/Clinical Investigator/Study Director, Management and reviewing corrective action plans.
• Reviewing of SOPs and Laboratory Systems {Qualification records - Installation qualification/Operational qualification/ performance qualification and 21 CFR Part 11 compliance}
  • Conducting in-life inspections to assure compliance with the GCP and GLP guidelines:
  • In-progress (critical phase) inspections, 
  • Facility (systems) inspections, 
  • Conducting audit of Clinical Data Management.

Achievements:

• Audited in-house clinical trials (Phase I and Phase II) for GCP compliance for NCEs RBx7796, RBx9841 and RBx11160 in the therapeutic area of Urology, Metabolic disorders and Malaria respectively. 
• Audited in-house studies for GLP compliance for NCEs viz., RBx4209, RBx9841, RBx10558, RBx11160, Piperaquine and Atorvastatin. 
• Audited BA/BE studies of Generic drugs for ANDA/ANVISA submission.
• Audited Bio-analytical/Analytical Method validation of Generic drugs/NCEs and stability data of NCE (in-house)/Generic (manufacturing location) for regulatory submission.
• Facility/system-based audit conducted to assure management for GCP compliance.
• Facility/system-based audit conducted to assure management for GLP compliance and preparedness to obtain Good Laboratory Practices (GLP) certification from National GLP Monitoring Authority. 
• Audited Clinical Database Management of NCEs RBx9841 and RBx11160 for studies (clinical trials phase I, II and III). 

May 2004 – October 2004:                        Pre-clinical Division

                                                                        Bharat Serums and Vaccines Ltd.,

Responsibilities:

• Preparation of Study Plan and study Reports as per OECD principles on Good Laboratory Practices.
• Principal investigator for toxicology studies.
• Coordinating, Monitoring and co-auditor for out-sourced studies with other CROs and research institution to ensure quality and timely completion. 

Achievements:

• Principal Investigator for acute and sub acute toxicity studies of anticancer drugs, anesthetics and anti-fungal drugs conducted according to OECD principles on Good Laboratory Practices.
• Study coordinator for studies on Safety and Efficacy of anticancer, anesthetics and anti-fungal drugs in dogs.
• Expertise in conducting of pharmacokinetic and pharmacodynamic studies in various animal models.

July 1999 – April 2004:                              Executive Research 

                                                                        SIRO ClinPharm Pvt. Ltd.,

(Formerly SIRO Research Foundation)

Responsibilities:

• Development of protocol, case report forms and investigator brochure.
• Conduct Qualification, Initiation, Interim and Closeout monitoring visits.
• Facilitation of ethics committee submission.
• Preparation pre-study documents.
• Monitoring -
• Verify subject safety and site adherence to ICH/GCP Compliance and FDA/EMA Regulations.
• Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
• Reviewing Informed Consent forms 
• Ensure complete and thorough study drug reconciliation (Investigational Product accountability).
• Tracking and review of completed case report forms, Query management, and Archiving of Case Report Forms and Study Related documents.

Achievements:

• Study Monitor for Head and Neck cancer clinical study (Phase III - EU submission) carried out at five clinical sites in 500 patients. This study was audited by independent international CRO for ICH GCP compliance (after 10 % recruitment of patients and at completion of 80 % patient recruitment) and found to be compliant.
• Study Monitor for Cervical cancer clinical study (phase III - EU submission) carried out at three clinical sites in 180 patients. This study was audited by independent international CRO for ICH GCP compliance and found to be compliant.
• Study Monitor for Phase III clinical trials carried out in Visceral Leishmaniasis (Kala azar) patients (n=300) at three clinical sites. 
• Study Monitor for Anesthetic study carried out at two clinical sites with 100 patients.
• Study Monitor for Phase II clinical trials carried out in Rheumatoid Arthritis in patients (n=180) at three clinical sites.
• Study Monitor for Phase II clinical trials carried out in Diabetic patients (n=120) at two clinical sites.

M. Pharm. Sci. (Tech), 1999, The Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai, Maharashtra – India, 400 098.

B. Pharm. Sci., 1997, Government College of Pharmacy, Vidyanagar, Karad (Satara), Maharashtra – India, 415 124.