Madan Kumar Gurusamy Email & Phone Number

14+years of varied experience in Pharma domain.Perform project linked activities associated with the compilation of client submissions to regulatory authorities, including paper and electronic formats. Responsible for the coordination, preparation and submission of various electronic formats such as ANDA, ANDAs, IND, NDA, Initial MAA, Annual Reports, Supplemental Information submissions, DMF submission and amendments, worldwide, assuring the quality and completeness of the submissions.Assist pharmaceutical and biotech companies to easily and efficiently make the transition to CTD and eCTD regulatory submissions.Conduct regulatory research on FDA, European and Health Canada Agency websites and assist during performance audits/assessments by the clients.Provide project management and publishing support for the publishing of regulatory submissions,ensuring timelines are met, the submissions are agency compliant and of quality.Work closely with internal project teams (technical, testing, sales) to ensure smooth technical delivery of projects.Business Requirement Document preparation. Handling of XML files.Training the clients on project flow & guiding for submissions, on-site submission guidance.My responsibility was to quality check documents, managing them using Liquient Insight publisher tool,providing hyperlinks, publishing and validating the submission using EURS validator.Handling all major European submissions, Initial MAA, CTA, Variations, (Type IA / IB and II), Line Extensions, Answer to Questions (A to Q), Supplemental Information submissions, PSUR, PIP, FUM and NeeS)Specialties: Electronic Submissions (eCTD), NeeS, SPL/PLR, PIM, Documentum and XMLeCTD/SPL Applications : PharmaReady, Liquent [IP (Insight Publisher), ISI Toolbox]Domain : e-Regulatory Compliance, 21CFR Part 11

Listed skills include Regulatory Affairs, Regulatory Submissions, Fda, Pharmaceutical Industry, and 32 others.