Kinjal is a highly qualified professional with more than 26 years of experience in core Corporate Quality Assurance functions exceptional strengths in understanding, developing and implementing Quality System in the field of GCP/GLP/GMP. Proven records of establishing successful Quality Systems & Regulatory Compliance and lead several regulatory inspections but not limited to DCGI, USFDA, EMEA, ANVISA, GCC, UK MHRA, MoH Malaysia, WHO.
Mr. Kinjal is a Post Graduate (Organic Synthetic drugs) & MTech. ( Pharmaceutical Operations) also possess a PGDBA degree. Mr.Kinjal is responsible for the implementation of Quality Assurance programme at the BE units located at Ahmedabad, Mehsana, Mumbai – India, Toronto- Canada and Pharmacovigilance. Prior to Joining Lambda He was also associated with pharmaceutical organization like Sun Pharmaceutical Industries Limited, Ranbaxy Laboratories Limited and Zydus Research Centre.
Ms. Robinson has 29 years of clinical research experience with Novum, progressing through a wide range of key positions with increasing responsibility. In a career spanning Clinical Operations, Protocol, Source document, and Case Report form development, Clinical Study Report Writing, IRB Management, Regulatory Affairs and Quality Assurance, Ms. Robinson currently has a senior director leadership role with Novum. She also assisted in the growth and development of Novum including supporting the establishment of Novum’s clinic sites. Ms. Robinson has extensive experience managing the more than dozens of Early Phase FDA audits during her tenure at Novum. She uses her vast operational and regulatory experience to develop and maintain Novum’s quality systems.
Dr Gauri Patel brings in over 15 years’ experience in Clinical Research and has been associated with Lambda for past three years. She is a Certified SQA [RQAP-GCP; RQAP-GLP] Professional and a Certified Trainer. Her Quality Assurance experience includes dealing with Quality Monitoring of procedures to ensure regulatory compliance for clinical, bio-analytical, and statistical phases of early phase studies as well as late phase clinical trials. She also has rich experience of fronting regulatory inspections.
With a firm understanding of GXP guidelines and regulations, her core strength areas are compliance assessment (monitoring; auditing; inspecting) and applied expertise (evaluation and advisory, remediation) towards achieving regulatory compliance. During her career, she has been a Speaker at various forums and has conducted quite a few GxP workshops for industry. Prior to Lambda Therapeutic Research Ltd., she has worked in Quality Assurance for leading CRO’s and was instrumental in pioneering and establishing training systems for the organization.