Sruthi Sundaram

Regulatory Affairs Specialist @Mdc Associates, Inc

Responsible for new client/sponsor on-boarding including attending client conferences, defining project scope and development of project proposals Development of U.S. FDA Pre-Submission, Informational Meeting or Determination Meeting Submissions Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies Development, compilation, review and submission of Regulatory Filings such as FDA EUA, 510(k), de novo and PMA submissions, EU Technical Files, etc. Interaction with regulatory agencies and Sponsors throughout the submission and review processes. Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms Assist with Institutional Review Board (IRB) submissions