PharExcel consulting is a full-service regulatory/clinical trial consulting firm for pharmaceuticals, medical devices, Herbals, Cosmetics and Nutraceutical Industries. Founded by Mr. Baburao Vikram who is a M.S. in Pharmacology & Toxicology from National Institute of Pharmaceutical Education & Research, Mohali, Punjab, India. Previously served for more than 15 years working in Pharmaceutical R& D, CROs and Academia. PharExcel consulting was founded on the premise that Medical devices, pharmaceuticals, Nutraceuticals and Herbal substances hold the future. We believe in transparency, realistic timelines, accurate submissions and an effective strategy to our clients. We take pride in delivering new solutions and excellent results for our clients. Medical device - ISO-13485 - CE marking - FDA 510K and Establishment registration - Notified device evaluation - Clinical evaluation reports as per latest revision - Technical files preparation for CE marking - PMCFs - Risk assessment report - Design and development - Clinical validation Clinical trial Services - Clinical trial management - Site management - Clinical monitoring - Patient recruitment - Post marketing studies Regulatory services: - CTD dossiers preparation - Module 1 to Module 5 - eCTD submissions