Ms. Anita Kaul
Saanvi Ethical Research LLP
- Ms. Anita Kaul has extensive experience of more than 30 years and expertise in Quality Assurance & Clinical Operations with demonstrated ability to effectively manage projects and people. Thorough knowledge of clinical research concepts, policies and local and international regulations (CDSCO, FDA, EMA, TGA, AGES, AEMPS, MCC). Worked in AIIMS, Ranbaxy Research Laboratories (now Sun Pharmaceuticals), Dabur Research Foundation and Cliantha Research.
- Initiated her journey of clinical research from Ranbaxy Research Laboratories now Sun Pharmaceutical. Responsible for Volunteer recruitment and management. By her hard work and dedication was made responsible for diagnostic laboratory and study coordination. Credited with getting the lab accredited by NABL. Assisted the head Clinical Pharmacology Unit in running and managing the unit.
- Credited with starting Quality Assurance unit for a pharmaceutical company and harmonizing the quality systems across department.
- Credited with starting and managing CRO unit site (Cliantha Research) with 200 bedded capacity for conducting BA/BE studies with CAP accredited diagnostic lab. Gave more than 8 years as Vice President Global QA head and operations head for the unit. Harmonized the quality systems across locations. Lead and mentored QA unit and clinical operations team to support successful internal training and its implementation, regulatory inspection process and developed proactive approach for inspection readiness.
- She is credited with starting and managing a CRO unit (Cliantha Research) site with 117 bedded capacity for conducting BA/BE studies with CAP accredited diagnostic lab. Worked as Vice President Clinical Operations. Provided leadership, strategic oversight and guided clinical operations team to ensure quality, timeline, resources and meeting budget goals.
Dr Geetanjali Uppal, MD Pharmacology
Saanvi Ethical Research LLP
- Dr Geetanjali Uppal, a Pharmacologist (MD) has been associated with Pharmaceutical Drug/Vaccine Industry for close to 17 years. Worked as part of clinical and regulatory teams in Multi Vaccine Development Programme, erstwhile Ranbaxy Laboratories Limited now Sun Pharmaceuticals Pvt. Ltd and Dabur Research Foundation.
- She has worked closely with other R&D teams to strategize and formulate Regulatory roadmaps for development of New Drugs (both NCEs and Differentiated drug products) and vaccines, vetted clinical and non-clinical development plans, extensively reviewed clinical and non-clinical data for scientific and regulatory compliance and supervised regulatory filings for Phase I/ II/ III clinical trials and NDA filing.
- She is credited with national and global NDA filing for Synriam, a new anti-malarial drug. She has worked in different therapeutic areas including Metabolic Disorders, Infectious Diseases, Antibiotics, CNS disorders, Respiratory Diseases and dermatological disease conditions predominantly acne and psoriasis. Her strengths include IND filing (India, US, EU) for NCEs and differentiated drug products, product development for global markets with focus on Integrated Product Development with most optimum regulatory and clinical path, Project Gap Analysis and formulating strategies to minimize product failure, designing clinical trial protocols and other CT related documents and Clinical and Non-clinical data review.
- Last placement before initiating Saanvi Ethical Research LLP was as Associate Director – Clinical and Regulatory Development, Multi Vaccines Development Program, New Delhi from 2017 – 2018. Profile involved complete functions including clinical, regulatory and project management involving preparation/review of CT documents, IND dossier submission and clinical operations for Phase I and II anti-malarial vaccine trials. Successfully filed IND for Phase I CT conduct with malaria vaccine with CDSCO.