With over a decade at Biocon Limited, my journey has been dedicated to mastering the nuances of API regulatory sciences, ensuring compliance and spearheading strategic initiatives in generic product regulations. Our team's collaborative efforts have been pivotal in the vertical integration and B2B customer qualification, contributing significantly to the registration, approval, and commercialization processes.

Leveraging a robust background in GLP, technology transfer, and regulatory affairs, I've cultivated a deep understanding of the product lifecycle from development to market. My leadership has furthered cost improvement plans and forged strong alliances with R&D, manufacturing, and quality teams, ensuring excellence in all facets of regulatory science.

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Ahmedabad Regional Office

Professional Engagement at NABL

• Joint Director, based at Ahmedabad Regional Office
• Overlooking the regional outreach activities in the western region and arranging/organizing awareness programs on NABL Accreditation and its benefits, with various business organizations, government organizations, academic institutions, chamber of commerce, professional institutions etc.
• Qualified Assessor for ISO 17025 (Testing and Calibration), ISO 15189 (Medical) , ISO 17034 (RMP) , and ISO 17043 (PT Providers).

Professional Experience:

• Rich experience of 20 years in the field with prior experience as a Microbiologist in Quality Control and Quality Assurance Department at Cipla Ltd and accredited food laboratories
• Conducted 35+ audits and made 100+ presentations at conferences and training programs. 
• Represented NABL at over 20 national and international forums. 
• Coordinated 61 training programs at the national and international level.

Professional Qualifications:

• PhD in Microbial Technology from Amity University
• M.Sc. in Microbiology from Mumbai University. 
• MBA, PG Diploma in Food Safety and Quality Management (PGDFSQM), 
• Professional Diploma in Quality Management (PDQM) 
• PG Diploma in Bioinformatics (PGDB). 
   

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Kumar Gaurav is a seasoned leader with over 22 years of experience in the vaccines and biologics industry, driving innovation, regulatory excellence, and global market expansion. His expertise spans product development, technology transfer, and regulatory strategy, playing a pivotal role in advancing vaccine portfolios from concept to commercialization.

A strategic thinker and dynamic leader, Kumar has spearheaded critical initiatives across the entire product lifecycle, ensuring seamless transitions from preclinical and clinical trials to market launch. He is actively engaged in global regulatory affairs, expanding vaccine access in international markets, and shaping the future of public health through cutting-edge vaccine innovations.

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Durga Prasad Erukulla working as Manager (Regulatory Generis Development) in Sandoz with overall 14years of experience in Regulatory Affairs department in various organizations, with this rich experience successfully submitted around 50 New Dossier submissions specially in US, EU, JP and some of ROW countries. His significant impact includes submissions without any rejection comments and the in-depth review of the sections that helps to avoid the major queries from Health authorities which benefits the industry to achieve first cycle approvals required for timely commercial launch of molecules for pioneering access to the patients.

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• MBBS (GSMC& KEMH, Mumbai, India 1991-1997) 
• MD (Pharmacology, TNMC& BYLNairH, Mumbai, India, 1997- 2000) 
• Dip. Diabetes (Apollo Hospitals, India, 2015-16), 
• PG Dip Infectious Diseases (UNSW, Australia), Fellowship in Diabetes (Royal Liverpool Academy, UK, 2018-2019),
• FCGP (Fellow college of General Practitioners (Indian Medical association, 2019)
• FRSPH (Fellowship of Royal Society of Public Health, London, UK, 2023), 
• FIPS (Fellow of Indian Pharmacological Society), 2023
• Ph.D (Public Health, CCU, 2019- 2022)
• Executive Program in Business Management (IIM – Calcutta, 2014-2015)
• MBA (Hospital Healthcare Management), BITS, PILANI, India, 2020-2022)
• FSASS(Fellow Scholars Academic & Scientific Society, 2023)

Senior pharmaceutical physician & medical pharmacologist, with > 25 years’ experience in Product Development, Project management, Preclinical Studies,, Clinical Trials, Regulatory, Pharmacovigilance & medical affairs.

Pharmaceutical Industry Experience- 25 years
 

• 2011- till date -  Hetero group (Hetero Labs, Hetero Drugs, Camber, Biopharma, Amarox, Annora) - Senior Vice - President & Medical Director Heading - Global operations of Clinical Trials, Pharmacovigilance, Medical Affairs (New Drugs/Biologics/ Discovery) . 
• 2001-2011- Previously led clinical trial and pharmacovigilance activities  at leading pharmaceutical organizations in similar roles including Dr. Reddy’s Laboratories (2003-2007), Vimta Labs(2009-2011), Indigene Alquest LLC.(2008-09) , Accenture ,  Glenmark,, Organon,  Khandelwal Laboratories.
• 1997-2001 - BYL Nair Hospital & TN Medical College (Medical Officer- Department of Pharmacology & Clinical Pharmacology & PV officer at National pharmacovigilance centre) . 

Pharmaceutical product development experience- 

• New chemical entities (HRF10071{HIV), 2-DG(Oncology}, DRF-2593{Diabetes}); NDDS (Long acting, sustained release drugs various TAs, Nail penetration antifungal, combination product, modified salts {antihypertensives, anticholesterolemic}), Biologics {13 biosimilars- Rituximab, Bevacizumab, Trastuzumab, Trastuzumab-Emtasnsine, Adalimumab, Denosumab, Darbepoetin alfa, Tenecteplase, Pembrolizumab, Tocilizumab, Filgrastim, Peg-filgrastim, Nivolimumab, Sputnik vaccine), Generics (150+). 

Project management -   Ideation, product development, tracking Preclinical studies, clinical trials, postmarketing studies. 

Preclinical Studies- Invitros, Pharmacology (pk &pd), Toxicology ( 300+ Acute, subchronic, long-term, mutagenicity & teratiogenicity, Rodent & Dog.   PDE reports- 10000+ (Supports cleaning & validation)

Clinical Trials/Research Experience – 

• a. BA/BE studies, Pk in patients, DDI, Clinical Endpoint- 500+ 
• b. Phase-3, Postauthorisation efficacy (phase-4) clinical trials, PMS, Investigator initiated studies (IIS), RWE studies-100+,  
• New Chemical/ Molecular Entities (NCEs/NMEs) in HIV, Diabetes & Cancer- Early phase phase-1, phase 2 studies. 
• Biosimilars in Cancer, Autoimmune diseases, Insulins, Hormones & Vaccines(Rituximab, Bevacizumab, Adalimumab, Trastuzumab, Trastuzumab Emtansine, Tocilizumab, Tenecteplase, Denosumab, Pembrolizumab, Erythropoietin analogues , Sputnik vaccine, Insulins, Recombinant Hormones)- Phase-1 & Phase-3 studies – Domestic and Global Clinical Trials. India, Russia, South America, Indonesia, Philippines, Australia.
• Multiple new Generics in various diseases including COVID-19 (Molnupiravir, Remdesivir, Paxlovid generic), HIV, Hepatitis - C(Sofosbuvir & combinations), Cardiology, Diabetology, oncology, gastroenterology, urology, haematology, orthopedics & rheumatology diseases - Phase-1, 3  & 4.
• 16 global meetings (USFDA, Mexico, Argentina, Turkey, Iran, Indonesia, Malaysia, Vietnam, Kenya, Zambia, South Africa, Kazakhstan, Russia, Moldova),

Pharmacovigilance Experience- 

• Established, led global pharmacovigilance/ medical safety at Hetero (Argus-safetysince 2011), at Dr. Reddy’s (Aris-g, 2003-07), Accenture (Clintrace, Abbott2008-09), Vimta Labs (2009-11) & BYL Nair Hospital& TN Medical College (PV officer at National pharmacovigilance centre; 1997-2001) . 
• Successfully faced approx. >100 regulatory inspections- USFDA, Europe, Mexico, Columbia, Indonesia, Malaysia, Canada, Kazakhstan,  South Africa   
• Academic - Adjunct faculty-Pharmacology at Kasturba Medical College (KMC), Manipal and at Indira Gandhi Institute of Medical Sciences ( IGIMS), Patna.
• PUBLICATIONS - Has 36 medical journal publications (original articles) in peer reviewed medical journals Authored two books ({AI in healthcare & Taste of Pharmacology][Available Amazon]) & 1 book chapter in a medical textbook taught in MBBS (Antihypertensives in Textbook of Pharmacology).

Awards

•  Bharat Gaurav Puraskar (KTK Foundation, (May 2024); 
•  Fellowship Indian Pharmacological Society (IPS, 2023); 
•  Lifetime achievement award (WEECE awards 2023),
•  India’s 10 most influential healthcare leaders (Tradeflock magazine May 2024

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Profile Summary:

I am Passionate, forward thinking Regulatory Affairs Leader with 19+ years of pharmaceutical industry experience in the field of Global Regulatory Affairs, predominantly in Regulatory Affairs CMC with the increasing responsibility of portfolio and people management.

In current role, Stabilized and strengthen the capability of the RA CMC and Device department in Bangalore India, which involves hiring line managers, associate directors and experienced Regulatory professionals in Bangalore India. Heading a department that works defines regulatory and device strategies for biological, biopharmaceuticals, small molecule, and Medical devices content (data and documentation) requirements for regulatory submissions and review the content for conformance with established requirements to provide best in class regulatory CMC strategies to the projects we support, thereby ensuring fast submissions and approvals globally. Ensures team effectiveness in working across a very complex matrix environment in RA with CMC RA leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.

I am motivated by the opportunity to make a positive impact on the lives of patients and the society through innovation, collaboration, and excellence.

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Academic background; Pharmacist in first degree and MSc in 'Medicine regulatory affairs

Current positions; Vice chairman of East African regulatory affairs Professionals association (EARAPA) for the last two and half years.

Currently working as Senior medicine registration expert at Ethiopian Food and Drug Authority (EFDA) And Lead GMP auditor of pharmaceutical companies at EFDA, Conducted official EFDA GMP audit of more than 16 Indian pharmaceutical companies and more others worldwide.

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Martina Gomes is the Regulatory Head for Bayer’s Consumer Health Division in India. She has over 16 years of Pharma and Consumer Health industry experience working in organizations like Pfizer & Sanofi across diverse portfolio of Biologicals, Specialty, Animal Health, OTC, Nutritionals and Ayush for South Asian countries. In her various roles, she has had opportunities to work closely on Health Authority interactions, Registration strategies, International product launches, Product life cycle expansions, business growth strategies and various other organizational projects. Martina has been involved with several Trade associations (OPPI, FICCI, Assocham, IDMA) for the last 15 years and has worked on several representations and initiatives to shape the external regulatory environment.

Martina strongly believes in building a regulatory framework and sustainable healthcare solutions to enable our Indian consumers to be in charge of their health and foster Self-care in our country.

Martina post-graduated from Sophia College, Mumbai with a Masters in Microbiology and further a degree in Clinical Research from the Bombay College of Pharmacy, Kalina. She’s an active member on the Board of Studies of Sophia College since 2021. She joined Bayer India in July 2020. In her earlier stint, she was the Head of Regulatory Affairs CH for South Asia at Sanofi.

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• M.Pharm -Pharmaceutical chemistry, RGPV India
• Advance Executive course – Corporate Strategy and Business Leadership, IIM Indore, India (Nov-2024)
• Pharma industry experience – 18+ years
• Regulatory Intelligence experience – 10+ years
• Current role: Associate Director, GRA, Regulatory Intelligence and Compliance at Advanz Pharma, UK.
• Past Roles: Regulatory EU submissions, Regulatory Intelligence, Operational excellence at CIPLA Ltd. India
• Professional Associations – Active member - RAPS INDIA, TOPRA Regulatory Intelligence SPIN CHAIR - 2023 till date

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With over 25 years of experience in the Biopharmaceutical Industry, Raja Sekhar Vanga is a recognized leader in regulatory affairs, specializing in the development and global registration of more than ten biosimilar products. He has successfully navigated complex regulatory landscapes to secure approvals for multiple biosimilar products across all the advanced markets and more than 100 emerging markets. Notable achievements include the U.S. FDA approvals of Ogivri® (first biosimilar trastuzumab), Fulphila® (first biosimilar PEG-filgrastim), and Semglee® (first interchangeable biosimilar insulin glargine), as well as the pioneering approval of biosimilar insulin glargine in Japan—the first by an Indian company.

Raja Sekhar has played a pivotal role in driving regulatory harmonization and engaging with global agencies such as the US FDA, EMA, PMDA, MHRA, ANVISA, NPRA, SFDA, and WHO, fostering alignment to facilitate market access.  

Additionally, Raja Sekhar orchestrated the seamless integration of Viatris' biosimilars business into Biocon, successfully transitioning over 400 product registrations globally within a 12-month period while ensuring continuity of product supply and operational efficiency. As a key contributor to Biocon’s success in the biosimilars space, he led the regulatory team behind the company’s landmark achievements worldwide in advancing biosimilar programs, improving patient access to affordable biologics.

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With over two decades of experience in the bio-pharmaceutical industry. Yogananda has established himself as a preeminent leader in Quality & Regulatory Affairs, particularly within the field of Biosimilar industry. His extensive expertise has enabled him to adeptly navigate the intricate regulatory landscapes, ensuring successful approvals for numerous biosimilar products across advanced markets worldwide.

As a key contributor to Biocon’s success in the biosimilars space, Yogananda has led the regulatory team to achieve multiple biosimilar product approvals in advanced markets. His leadership has been pivotal in enabling access to high-quality, affordable biosimilar medicines in advanced markets, thereby improving patient outcomes and fostering innovation within the industry.

Among Yogananda's notable achievements are securing approvals from prestigious agencies such as the U.S. FDA, EMA, PMDA, and MHRA for groundbreaking biosimilars like YESAFILI, the first interchangeable biosimilar Aflibercept, and YESINTEK, a biosimilar Ustekinumab and Insulin Aspart Biosimilar. His commitment to regulatory harmonization has been instrumental in fostering alignment with global agencies, including the U.S. FDA, EMA, PMDA, MHRA, TGA, and Swissmedic, thereby facilitating the approval of biosimilar products.

In addition to his regulatory accomplishments, Yogananda successfully orchestrated the seamless integration of the Viatris Biosimilar business into Biocon. This complex transition, which involved multiple biosimilar products across advanced markets, was completed within a 12-month period, ensuring continuity of product supply and operational efficiency.
 

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Yaziid Kakembo is a seasoned pharmaceutical regulatory affairs professional with over seven years of experience at the National Drug Authority (NDA) of Uganda. Currently serving as a Regulatory Officer and Coordinator for the IGAD Medicines Regulatory Harmonization (MRH) joint assessments, he plays a pivotal role in the technical evaluation of CTD dossiers, regulatory decision-making, and GMP compliance inspections for human, veterinary, and complementary medicines, including vaccines and other biologicals.

Yaziid holds a Master of Science in Biotechnology Innovation and Regulatory Science from Purdue University, USA, and a Bachelor of Pharmacy from Mbarara University of Science and Technology, Uganda. His expertise spans quality assurance, regulatory system automation, regional harmonization, and capacity building, having led the development of assessment templates and trained regulatory assessors across East Africa.

He is actively engaged in continental reliance frameworks, policy development and has participated in high-level trainings and workshops organized by IGAD, WHO, Swissmedic, and PMDA. A certified member of the Pharmaceutical Society of Uganda and the Regulatory Affairs Professionals Society (RAPS), Yaziid is passionate about leveraging science and collaboration to strengthen regulatory systems across Africa.

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Rahul Gupta is presently Sr. Vice President – Regulatory Affairs at USV Pvt Ltd. Prior to USV, he has worked in Sun Pharma, Piramal enterprise and many other pharmaceutical companies. Rahul has over 30 years of experience in the various pharmaceutical area. He has regulatory experience for development of new molecules from discovery to Phase I to Phase III. He has worked on cancer, anti-analgesic, anti-infective, metabolic disorder drugs in area of new drug development- having experience of successfully filing about 60 Phase I / II and III IND / CT applications across various continent, which includes USA, Europe, Australia, Canada and India. He has also worked on more than 100 ANDA’s and generic European submission for various dosage form- solid orals, parenterals, nasal sprays and complex generics etc, also having large experience of DMFs/CEPs/ASMFs in regulated countries. He was also an adjunct faculty at Mumbai University (Bombay college of pharmacy), NMIMS and many other academic institutes in India.

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Akshaya S. Odak is currently Head – Regulatory ‐Biotechnology Division of Lupin limited based in Pune, Maharashtra. Prior to that, he was looking after the regulatory function for the registration of Biotechnology products of Wockhardt Limited, Aurangabad. During regulatory tenure, worked primarily on biosimilars and has a vast experience of regulatory dossier filing and product approval in US, EU, Japan, Australia, Canada, India and more than 70 countries. He has also faced regulatory audits from different agencies viz., US FDA, EU, PMDA, ANVISA, GCC and other countries. He has an industrial experience of around 32 years and has also worked for companies like Hoechst India Ltd., and Ranbaxy Laboratories Ltd. His prior experience included development and production of Biologics. He has done his Master’s, M.Phil., and Ph.D. from Jiwaji university, Gwalior.

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Anand Saxena serves as the Director of Regulatory Affairs at Cipla Limited, bringing over two decades of expertise in the field. With a postgraduate degree in Organic Chemistry, he has built a distinguished career in regulatory strategy and compliance. In his current role, he leads and manages a team overseeing regulatory activities, including ANDA and NDA submissions, deficiency response, and post-approval lifecycle management. His extensive experience spans a wide range of dosage forms, including oral, complex injectables, topicals, ophthalmic, respiratory inhalation products, and nasal sprays.

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Juliet Rebello leads the clinical strategy and development for 505(b)(2) products at Cipla Ltd. She has over 20 years of clinical research experience in different therapeutic areas. She also heads the medical writing team at Cipla Ltd.  Her current work focuses on advancing new capabilities, methodological strategies and pragmatic approaches to include real world evaluations in drug development. She maintains a strong passion for innovation and use off right kind of modeling approaches to de-risk and accelerate drug development.  She has co-authored more than 10 publications in high-impact, peer-reviewed journals and given several presentations at national and international meetings.

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• Sudheendra Kulkarni, Ph.D., AVP – Regulatory Policy, Government Affairs & Audit Liaison 
• Dr. Sudheendra is currently working at Biocon Biologics Limited, Bangalore as AVP – Regulatory Policy, Government Affairs & Audit Liaison. 
• Dr. Sudheendra, earlier worked at U.S. Food and Drug Administration, New Delhi Office as Senior Technical Advisor - Bioresearch Monitoring and Medical Devices
• Dr. Sudheendra worked closely with OGPS Senior Leadership and USFDA India Office Senior Management for the extension of MOU between MoHFW and USFDA. He was awarded Superior Honor Award for the efforts to sign bilateral MoU. 
• Dr. Sudheendra served as a key member for the planning and execution of USFDA Commissioner visit to India. 
• He also served as Head Quality Assurance for Syngene Clinical Development before moving to USFDA India Office in 2018. 
• He holds a Ph.D. in Biochemistry from Gulbarga University, Gulbarga.
   

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