Experience

ZEUS HYGIA LIFE SCIENCES PRIVATE LIMITED

• India
• Biotechnology Research
• 1 - 100 Employee

• Leading - Nutraceutical Product Development

  • Apr 2017 - Present

  Hyderabad Area, India



Sarvotham Care Ltd

• Deputy General Manager - Regulatory & Clinical Affairs

  • Aug 2016 - Mar 2017

  Hyderabad Area, India Preparation, review, submission of registration documents for product approval of drug, food/food supplements, Health supplements, Nutraceuticals, Additives and ingredients. Preparation, review, submission of registration documents for scientific panel of drug, food/food supplements, Health supplements, Additives and ingredients. Conducting and coordinating human and animal pharmacokinetic & efficacy trials. Scientific study support to product development, regulatory &… Show more Preparation, review, submission of registration documents for product approval of drug, food/food supplements, Health supplements, Nutraceuticals, Additives and ingredients. Preparation, review, submission of registration documents for scientific panel of drug, food/food supplements, Health supplements, Additives and ingredients. Conducting and coordinating human and animal pharmacokinetic & efficacy trials. Scientific study support to product development, regulatory & marketing. Experience in providing product claims, health claims and nutrient claims of drug, food, food supplements and health supplements products so as to get competitive advantage. Experience in regulatory assessment of formulation development in drug, Food/ Food supplements, Health Supplements and Nutraceuticals. FSSAI Documentation, Label validation, Product approval or NOC for food product as per FSSAI, FSSAI Licensing, FSSAI Import, FSSAI regulations compliance. Actively involved in preparing dossiers covering food products for submission to US, EFSA, ASEAN, AYUSH and FSSAI. Show less



OmniActive Health Technologies

• United States
• Wellness and Fitness Services
• 300 - 400 Employee

• Senior Clinical Research Manager

  • Oct 2013 - Jul 2016

  Thane, Mumbai Expertise on Nutraceutical molecules i.e. Lutein, Curcumin, Capsicum, Zeaxanthin, Beta-cryptoxanthin, Ginger, CoQ10, Milk Thistle etc... New dietary ingredient research: Characterization, DMPK, efficacy models, toxicology research, animal PK Study, human bioavailability study and human clinical trials. Conducting and coordinating human and animal pharmacokinetic trials. Expertise in Nutraceutical regulatory agents: EFSA, USDA and FSSAI. Threapeutic area: Obesity… Show more Expertise on Nutraceutical molecules i.e. Lutein, Curcumin, Capsicum, Zeaxanthin, Beta-cryptoxanthin, Ginger, CoQ10, Milk Thistle etc... New dietary ingredient research: Characterization, DMPK, efficacy models, toxicology research, animal PK Study, human bioavailability study and human clinical trials. Conducting and coordinating human and animal pharmacokinetic trials. Expertise in Nutraceutical regulatory agents: EFSA, USDA and FSSAI. Threapeutic area: Obesity trials, ARMD trials(eye health), tolerability/efficacy trials and Skin trials. Bio-active nutrients, Dietary supplements, Nutraceuticals, Nutrition in health, Pharmacology; Physiology and Biostatistics.

• Clinical Studies Manager

  • Aug 2008 - Sep 2013

  Mumbai Area, India Identifying and screening New Dietary Ingredient (NDI). Regulatory support for excising products / NDIs approval and claims. Manage/support regulatory related activities to new/existing products; contribute to development and implementation of optimal regulatory strategies. Monitor current scientific literature for new information in health and nutrition that can be applied to, or result in, new products or claims. Planning and conduction pharmacological studies for NDI and… Show more Identifying and screening New Dietary Ingredient (NDI). Regulatory support for excising products / NDIs approval and claims. Manage/support regulatory related activities to new/existing products; contribute to development and implementation of optimal regulatory strategies. Monitor current scientific literature for new information in health and nutrition that can be applied to, or result in, new products or claims. Planning and conduction pharmacological studies for NDI and existing products. Project management of Clinical Trials/Animal Studies through CRO's/Institutes. Conducting and coordinating animal efficacy, bioavailability & clinical studies. Preparing and Reviewing the Protocol, CRFs, ICFs, Clinical Reports and clinical trial related documents. Coordination with CRO and other educational Institutes for proper conduction of the clinical study/ animal study. Doing statistical analysis for clinical trials/pharmacokinetic trials. Author and/or work with others to develop publications based on the results of the clinical trials/animal studies. Participates in the preparation and presentation of data, when applicable. Perform literature searches, research, and overall administrative assistance. Design or assist in the design of science based products. Providing effective Scientific & Technical Stewardship for the Nutritional Healthcare Business in support of the business purpose. Worked closely with marketing divisions to develop health-related messages for brands. Contributes to projects that support wider organizational goals. Oversee, design, plan and develop clinical evaluation research studies. Participates in and/or leads study development and start-up process including development and review of study related tools. Participate in the design of clinical trial studies in collaboration with senior management, clinical project manager, medical monitor, biostatistician, and regulatory affairs.



Sitec Labs Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Clinical Research Associate-Group Leader

  • May 2004 - Aug 2008

  Mumbai Area, India Preparing and reviewing Protocol, CRF/ ICF, Coordination Forms, Interim, Drafts and Final Reports. Coordinating with the Principal Investigator, Clinical Head Operations and the Study Director. Handling pharmacokinetic and statistical analysis of PK parameters by using Winnonlin & SAS Software. Implementing strategies in coordination with Sponsor’s Representative, Principal Investigators, Quality Assurance Personnel, Statistician, Study Coordinator and Laboratory Assistant for assuring… Show more Preparing and reviewing Protocol, CRF/ ICF, Coordination Forms, Interim, Drafts and Final Reports. Coordinating with the Principal Investigator, Clinical Head Operations and the Study Director. Handling pharmacokinetic and statistical analysis of PK parameters by using Winnonlin & SAS Software. Implementing strategies in coordination with Sponsor’s Representative, Principal Investigators, Quality Assurance Personnel, Statistician, Study Coordinator and Laboratory Assistant for assuring proper & successful conduction of clinical phase of bioequivalence. Attending IEC meetings with the Principal Investigator. Show less



SUN Pharmaceuticals (P) Ltd

• Medical Representative

  • Jan 2000 - Mar 2002

  Madurai Area, India Promoting new drugs to doctors and physician (Neuro-psychiatric drugs). Discussing dosage, use, and effect of new drugs and medicinal preparations. Giving samples of new drugs to doctors. Launching new drug molecules in Neuro-Psychiatric segment.