Murali K.

I am a Regulatory and Quality Consultant with an expansive regulatory and quality experience with OTC drugs, Food Supplements, Cosmetic products, and medical devices. Over the last 20 years, I've held various senior level management positions within global companies. I started my career as an Analytical Chemist and held my most recent position in a QA / RA Consulting agency. I have experience in regulatory requirements for the US, EU, Canada, Australia, Singapore, Malaysia, Philippines, Taiwan, India, and other semi-regulated markets as well.! Some of my other specialties include product dossie authoring and review, technical files compilation , regulatory submissions, writing SOPs working in QMS (Overall Quality Management) environment and Systems that comply with ISO standards, and various worldwide regulatory entities. I am well-versed in research skills and good at regulatory intelligence too,! My Expertise and favorite thing is product compliance, product classification, and label compliance review. I can review your, OTC drug, Food Supplement, Food Products, and Cosmetic labels for compliance to the US FDA, EU Directives, Health Canada, and GCC countries Expert in Regulatory compliance for Cosmetic Products for regulated markets like US, EU, UK, China, Japan, Canada, Singapore, Malaysia, and India. - Cosmetic Product Classification, - Preparation of regulatory strategy for respective health authority, Labeling Compliance, Formulation Assessment for ingredients acceptability for restriction limits as per end use and end user. - Claims Assessment for acceptability and substantiation as per HA requirement. - Safety assessment for the cosmetic product. Review of Cosmetic Product Safety Report (CPSR). - Preparation of Production information file (PIF) file. - Product notification/registrations through CPNP, eCOSMA and MOCRA - FDA DIRECT portals. Worked on various product categories like Skin Care, Hair care, Pain care, and dermal care products, and worked on products like Aveeno, Neutrogena, Clean and Clear, Noskurf lotion, Triclenz, and Triflow for new market launch (GCC countries). Regulatory exposure in cosmetic and health care products, Expert in EU cosmetic regulations (EC) N° 1223/2009, US Title 21 CFR Part 700, Canada, Australia, and ASEAN Cosmetic Directive (ACD), and GCC countries. Having a very good exposure in Dossier management, Compilation of data for CTD module-1, 2, and 3, and Regulatory Submissions for various markets like the US, EU, Canada, and ASEAN markets for Health care products (OTC). I work efficiently, ensuring each task meets high-quality standards, and I'm always prepared to engage with clients regarding any work-related matters.