Mr. Apurva Shah is a founder and Director of Veeda Clinical Research. He has a MBA in International Finance & Entrepreneurship from Babson College in Boston USA. With his strong entrepreneurial and organizational skills, he has been able to grow Veeda to become one of the premier CROs in the country. As a Board member, he gives strategic and financial direction to all Group Companies. Mr. Shah strongly believes in giving back to the society and hence as a Managing Committee member of the NGO 'Each One Teach One' (www.eotoindia.org) he helps in furthering the cause of education and development of under privileged children in cities and tribal areas. During his tenure as the Chairman of Association of CROs in India (www.acroindia.org) from 2010-2014, he was able to grow the association membership 5 fold, increase the awareness of the industry and work with the Regulatory Agencies to facilitate the growth of the industry. He believes that if done in an ethical manner, clinical research is a very attractive socio-economic opportunity for India. He is on the Governing Board of the Life Science Sector Skill Development Council (www.lsssdc.in) set up by the Government of India. He has also been a member of the Pharma committee of CII for the past 5 years. Mr. Apurva Shah and Mr. Binoy Gardi were awarded the prestigious Entrepreneur of the year in 2009 by the BioSpectrum magazine as recognition for his contribution to the industry and were awarded the SME Entrepreneur of the year by Business Today and Yes Bank in 2010.
Mr. Binoy Gardi is a founder and Director of Veeda Clinical Research. Mr. Gardi is responsible for strategic planning, developing and implementing new services and establishing relationships with the firm's growing client base. His entrepreneurial vision has led the Company to become one of the fastest growing CROs in India. Mr. Gardi also spends part of his time pursuing his philanthropic ventures. He is responsible for setting up and running two 500 bed hospitals in India. Both hospitals offer free healthcare and medicines. He is one of the main Trustees of RD Gardi Medical College which has now 150 seats and a total of 850 students for MBBS and post graduate courses. Mr Gardi is also Managing Trustee of Shri Bharat Saraswati Mandir Sansad Trust, this is one of the oldest trusts in Gujarat and has 16 educational units with over 3000 students. Mr. Gardi has won the Entrepreneur of the year in 2009 by BioSpectrum magazine and was awarded the SME entrepreneur of the year by BUSINESS TODAY and YES BANK in 2010. Mr. Gardi has a BSc in Business Management from Kings College London and is also a qualified lawyer from the UK. He has also received a diploma from London Business School in Investment Management.
Dr. E. Venu Madhav has a Ph.D in Pharmacy with an MBA in Finance and has 25+ years of rich experience in CROs and Pharmaceutical companies like Ranbaxy & Sun Pharma. He has a demonstrated expertise in executing Biostudies from Pilot to Pivotal stage for different formulations like Injectables, Nasal sprays and Topical preparations besides Conventional dosage forms. He has handled special population studies including patient population studies for oncology products. He has hands on experience in designing Protocols for IND/NDA/ANDA projects. He has been responsible for developing Complex Bioanalytical methods for Hormonal, Steroidal and Peptide products. He also has an expertise in Pharmacokinetics, Statistical evaluation of data and providing technical write ups to Regulatory Authorities. During his tenure, he used to handle Regulatory queries of US, Europe, Australia, Canada, Brazil, Japan and other Regulatory Authorities on study designs, GLP/GCP Compliance and Regulatory compliance. He has so far handled 50+ Regulatory Inspections from across the Globe successfully. He also has a thorough knowledge in Biostudies Project Management.
Mr. Nirmal Bhatia is a Chartered Accountant, Company Secretary, LLB and PGDBA in Finance handling all the national and international operations in Veeda. Mr. Bhatia has 27 Years of experience in handling Finance, Accounts, Treasury, Internal Finance Control Systems, Business Planning, Legal, Taxation (Domestic and International), Company Secretarial and Allied Laws, Costing, Management Information Systems, Inventory management and Mergers and Acquisitions. He has worked with many multinational organizations like Suzlon, Pepsico and Deloitte at various senior positions in the past.
Dr. Bordoloi is a medical graduate with a MD in Clinical Pharmacology and a Post Graduate Diploma in Business Management. He has over 16 years of rich experience of working with Hospitals, Pharma - Biotech companies and CROs of global repute, where he had played key roles in Clinical Trial Management, Medical & Regulatory Affairs and Pharmacovigilance.
Dr. Bordoloi has successfully lead designing, strategizing and execution of various projects in drug development domain starting from preclinical studies to post marketing safety monitoring, this also includes over fifteen Biosimilars molecules. He has successfully handled several regulatory inspections including USFDA and MHRA.
Prior to joining Veeda CR, he has worked for Cipla, Ethypharm LL Pvt. Ltd, Intas, Jubilant Clinsys and Lambda Therapeutic Reasearch Ltd. In his last assignment, as a Senior General Manager at Lambda Therapeutic Research Ltd.., he was heading the Pharmacovigilance business unit and was responsible for strategy, global operations and business development for the unit.
Mr. Jitendra Parmar is working as Head-Biopharmaceutics & Project Management at Veeda Clinical Research. By qualification, he holds Masters in Pharmaceutical sciences and has about 14 years of experience in pharmaceutical research.
He started his career as formulation development scientist, and later got involved in biopharmaceutics and pharmacokinetics research aspects of generic drug product development. He has been involved in audits, monitoring and selection of various national and international CROs and is well versed with various aspects of design, conduct & evaluation of bioequivalence studies for different regulatory markets.
He has extensively dealt with several ANDAs and First to file projects of different dosage forms and complex products starting with Solid orals (Simple to Complex Modified release Tablets, capsules), Transdermal patches, Injectables, Inhalation (Nasal sprays, pMDIs, DPIs), Topicals (Creams, Ointments, Gels).
Mr. Parmar has exposure to various bioequivalence approaches ranging from In vitro, in vivo studies (PK/PD), Scintigraphy studies and Clinical Endpoint studies like permeability studies, In vitro Dissolution and Correlations, In vitro BABE for Nasal sprays, Pharmacokinetic BABE studies, Pharmacodynamic studies (Vasoconstriction, FEV1/Methacholine challenge) and Clinical Endpoint studies (Ulcerative Colitis, Acne, etc).
Mr. Jitendra Parmar has vast exposure of pharmaceutical research, prior to joining Veeda CR in CRO industry, he has worked with various Pharmaceutical companies like Cadila Pharmaceuticals Limited, Sandoz Private Limited, Zydus Cadila and Alkem Labs Limited in various positions from Trainee scientist to General Manager.
Mr. Jitendra Parmar was leading the Centre of Excellence of Respiratory Product Development at Zydus Cadila wherein he was accountable for overall management of projects from the project award to ANDA submission, including formulation development, analytical and Clinical aspects, subsequently worked at Alkem Labs Limited as General Manager-product development, He has overall good understanding of various facets of drug product development and Clinical research.
Mr. Rudolph Pinto is a seasoned HR professional with 18 years of rich experience from top global and Indian MNCs. He has a solid background in HR and his association with major Pharma companies is a value addition.
Rudolph assumed this role in 2016 and is responsible for the company's Human capital management strategy, envisioning the roadmap for HR and developing the talent and leadership needed to foster innovation and growth.
His major areas of interest are recruitment, training, performance management and employee engagement.
Mrs. Amee Kanuga is functioning as an Head - Quality Assurance of Vedant facility of Veeda Clinical Research and is responsible for managing audits and quality assurance related deliverables for Vedant facility. She has faced several regulatory audits and inspections from leading regulatory bodies including but not limited to DCGI, USFDA, ANVISA, AGES, UK MHRA, ANSM, WHO.
Mrs. Amee Kanuga is an M.Sc in Organic Chemistry and having "Professional Diploma in Clinical Research (PDCR)" from Catalyst Clinical Services, Delhi. She has about 14 years of experience in Quality Assurance of CRO based Industries. She possesses Good working knowledge of the Clinical Research processes, Good Clinical Practices, Good Laboratory Practices, and relevant Regulatory requirements. Mrs. Amee had successfully completed the exam conducted by Society of Quality Assurance, USA and had received title RQAP-GLP (Registered Quality Assurance Professional Good Laboratory Practices). She has been working with Veeda for over 12+ years. Prior to Veeda, she was associated with Lambda Therapeutic Research working in quality assurance department.
Finance Team is guided by Mr Nirmal Bhatia who is a Chartered Accountant, Company Secretary, LLB and PGDBA in Finance handling all the national and international operations in Veeda Clinical Research. Mr Bhatia is having 29 Years of experience in handling Finance, Accounts, Treasury, Internal Finance Controls Systems, Business Planning, Taxation (Domestic and International), Company Secretarial and Allied Laws, Costing, Management Information Systems, Inventory management and Mergers and Acquisitions.
Under his guidance there is a team of 18 people including 2 CA and 3 MBA in Finance having in depth knowledge of various tax and other related commercial laws.
Business Development Team is headed by Dr. E. Venu Madhav who is COO of the company and has a Ph.D in Pharmacy with an MBA in Finance and has 25+ years of rich experience in CROs and Pharmaceutical companies like Ranbaxy & Sun Pharma. He has a demonstrated expertise in executing Biostudies from Pilot to Pivotal stage for different formulations like Injectables, Nasal sprays and Topical preparations besides Conventional dosage forms. He has handled special population studies including patient population studies for oncology products. He has hands on experience in designing Protocols for IND/NDA/ANDA projects. He has so far handled 50+ Regulatory Inspections from across the Globe successfully. He also has a thorough knowledge in Biostudies Project Management.
Under his direction there is a passionate team of 9 out of which 4 looks after the core business development globally, and rest works in the backend to support them. All our business development mangers are having experience of more then 10 years and have in depth understanding of scientific expertise of the services as well as excellent client relationship management.
The vibrant and enthusiastic HRD team is been led by Mr. Rudolph Pinto who carries enriched experience of 20 years in the field. He carries in depth experience of all the HR functions which fosters individual career growth and development of employees working at Veeda Clinical Research. Under his guidance there is a team of 8 holding master degree in HR out of which there are 2 managers having more than 10 yrs of experience and rest having of more than 5 yrs of experience. HRD team steers the employees and company towards new milestones. HR Team at Veeda Clinical Research has got varied experience in various facets of Human Resources and believes in openness which empowers employees with freedom of thought and expression. With expertise knowledge imbibed in the team we thrive for quality and aspire to sustain. A healthy work life balance is what HRD team works thus creating a lively and energized culture always focusing on improvement.
Mrs. Amee M. Kanuga, RQAP-GLP, is an M.Sc in Organic Chemistry with Professional Diploma in Clinical Research (PDCR) and having about 16 years of experience in Quality Assurance of CRO based Industries having good working knowledge of the Clinical Research processes, Good Clinical Practices, Good Laboratory Practices, and relevant Regulatory requirements.
QA team comprises of around 17 pharmacy post graduates having good experience in Clinical research processes. Team includes enthusiastic professionals having work experience in quality assurance from different CRO and pharma industries. Team has experienced in auditing complex studies including clinical phase and bioanalytical phase. Team has faced good number of regulatory inspection and is experienced in handling client audits as well as regulatory inspection.
At QA, our purpose is clear and we are passionate in our tasks. Meaning of Quality to our team is constantly pursuing excellence and keeps it improving. Our values guide our decision and actions. Each values of company are incorporated in our daily tasks to ensure that each employee abides by it.
Clinical Operations at Veeda Clinical Research is headed by Dr. Pranjal Bordoloi. He has over 17 years of rich experience of working with Hospitals, Pharma – Biotech companies and CROs of global repute, where he had played key roles in Clinical Trial Management, Medical & Regulatory Affairs and Pharmacovigilance.
Veeda’s Clinical Operations Department (COD) has a dedicated team of 30 experienced professionals in different functionalities of Project Management, Medical Writing & start-up and Medical Monitoring. This includes 5 project managers (average experience of more than 10 yrs), 3 medical monitors (lead by MD Pharmacology), 3 medical writers (average experience of 7 years), 4 clinical team leaders (average experience of 7 years), 12 CRAs (including 4 regional CRAs) and 3 clinical trial assistants (CTAs). As a team we have completed 29 clinical trials (Phase II, III and patient BA BE studies) in various therapeutic area such as Oncology, Psychiatry, Ophthalmology, Rheumatology, Cardiology, Dermatology, HIV and bone diseases. Clinical Operations team at Veeda has successfully faced total seventeen (17) USFDA inspections at Investigator sites (at which Veeda had conducted PK studies) with no adverse observation.
Mr. Jitendra Parmar heads the Bio pharmaceutics & Project Management Team in Veeda CRO. By credentials, He is post-graduate in Pharmacy and having more than 15 years of rich and diverse experience. Under his guidance there is a team of about 48 clinical research scientists, which includes 11 most experienced project managers consists of blend of technical knowledge and acquired management skills. Project managers are mostly post- graduates (i.e. pharmacology, QA, biochemistry) and having pharmacy background.
Bio pharmaceutics Team functions in start to end fashion during project life cycle and handles various steps i.e. feasibility, study initiation, protocol writing, coordination for regulatory submission, developing of study milestones, study updates to sponsor, final report dispatch. Team possesses experience of operations for varied set of activities (i.e. pharmacy management including investigational medicinal product handling (i.e. receipt, dispensing, reconciliation, and disposal), coordination, online monitoring, and facing regulatory inspections). Having vast experience in understanding the challenges of study design and logistics of study execution we ensure Quick turnaround time to sponsor proposal/inquiry on technical aspect of study (i.e. study design, evaluation criteria) in cost effective manner.
Medical Affairs and Pharmacovigilance at Veeda Clinical Research is headed by Dr. Pranjal Bordoloi. He has over 17 years of rich experience of working with Hospitals, Pharma – Biotech companies and CROs of global repute, where he had played key roles in Clinical Trial Management, Medical & Regulatory Affairs and Pharmacovigilance.
Under his leadership there is a team comprises of Pharmacovigilance associates having qualification of Masters in Pharmacy with an average experience of more than 5 years and medical reviewers including MD Pharmacologists. The team is well trained and experienced with all Pharmacovigilance related activities complying with regulatory requirements of USFDA, EMEA, MHRA, CDSCO/PvPI and Middle East countries. The team’s capabilities includes case processing, aggregate report writing, signal management, clinical trial safety management, literature screening, medical information management, PSMF development, risk management plans, risk evaluation and mitigation strategies and signal management.
CRD Team is headed by Dr. Rupesh Vala. By qualification, he is a MBBS, and has joined Veeda with 16 years of industry experience in clinical research. He is trained and well versed in basic pharmacology, clinical pharmacology, GCP, GLP, clinical studies and medical writing.
Under his guidance CRD team consist of 12 medical Doctors in the team, 2 of them are Clinical Pharmacologist with M.D. and 10 are MBBS Doctors. In past 2 years we have done more than 415 BA BE studies in different formulations such as Glucose clamp, Transdermal Patches, Long Acting Injectable, Suspensions, ODTs, suppositories, etc. Team has successfully completed 13 USFDA audits.
Lab operations are guided by Mrs. Swati Guttikar she is having vast experience of 27 years in Bio analytical field. She is Masters in Pharmacy with specialization in Pharmaceutical Chemistry and has technical and scientific expertise. Under her leadership the team comprises of almost 300 trained staff. Senior team is associated with Veeda since its inception and is very well versed with the Guidelines and regulatory requirement.
The team as a whole is scientific and quality oriented. We have extensive expertise in developing sensitive methods for LC-MS/MS – qualifying multiple-analytes, metabolites, prodrugs, endogenous, enantiomers, isomers and light/temperature-sensitive compounds. The team has developed and validated Endogenous, hormonal, positional isomers, Chiral isomers, plasma unstable molecules such as Phytonadione, Ethinyl Estradiol, Atorvastatin +metabolites, R and S Ibuprofen, Penicillamine etc. The team also has wide experience in complex molecules, NCE molecules & Elemental analysis. The team is very well versed with Biosimilars like Insulin, C peptide, GCSF by Elisa methods .The team has successfully completed first to file studies within very less time where all different groups combined and work only on a single project to achieve the timelines. Veeda Lab has successfully completed many audits from USFDA, MHRA, WHO, ANVISA, NPRA (Malaysia) and other regulatory agencies.
The young and energetic ICT team is led by Mr. Rajesh Limbachia who is having more than 17 yrs. of experience in the industry and is a certified lead auditor in ISO 2701. He also holds green belt in Six Sigma and is expert in cyber security and ethical hacking. Under his direction there is a team of 13 IT Professional and experts in multiple fields of Hardware, Software and Networking technologies.
All the IT systems in the company are 21 CFR part 11 compliant and ICT Team is responsible for day to day building and maintaining Veeda’s IT Infrastructure to ensure Confidentiality, Integrity and availability of sensitive information of Veeda.