Dr. Rupali Paranjape is one of the Asia's top award winning global pharma leader and the Founder of Blue Ocean Compliance, a firm offering various quality, compliance and training related services to the Pharma Industry. She has 2 decades of experience working with Multinational Pharmaceutical Companies in leading roles in the field of Regulatory Affairs, Compliance, Quality Control (Formulation and API), and ADL(Formulation).
Dr. Rupali is well-versed in facing Regulatory Inspections of the USFDA and MHRA. Working as a Compliance professional, she has faced USFDA with Zero 483s, having experience in making non-USFDA approved Intermediates, and API manufacturing sites to USFDA Approved sites.
As a Regulatory Professional, she has experience in successfully filling DMF, ASMF, and CEP for API and ANDA, and MAA for Drug products, with regulatory agencies.
Dr. Rupali guides pharmaceutical companies in preparation for regulatory inspections, in attaining compliance and saving huge costs due to non-compliance and also aids the companies that are facing regulatory challenges to overcome the same, by performing audits of the facility for GAP analysis, risk assessment, and suggesting the CAPA for regulatory actions/GAPs and imparting training. Helping them by suggesting a plan of action, and to respond to Regulatory Authorities.
She contributes to the greenfield projects, QA & QC setup of Pharmaceutical Companies.
Dr. Rupali empowers Professionals working in Pharmaceutical Industry to increase their competency and live their life with legacy, fulfillment, and abundance.
She is helping pharmaceutical companies by training their employees in cGMP as per the requirement of 21 CFR211.
She is:
She has been bestowed with two International & three National Awards in the year 2022. Some of the notable awards presented to her are: