CMC Technical Writing: A Critical Enabler During Product Development
Deblina Rababi
25 Jun, 2025
Deblina Rababi is an experienced regulatory professional specializing in medical device compliance under EU MDR. She has expertise in authoring and reviewing Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Literature Search Reports (LSR), Periodic Safety Update Reports (PSUR), Post-Market Surveillance Reports (PMSR), and Post-Market Clinical Follow-up (PMCF) documentation.
As an Associate Manager at Celegence, she ensures the development of high-quality regulatory submissions, supporting medical device manufacturers in achieving compliance. Her detail-oriented approach and regulatory expertise contribute to streamlined documentation and successful audits.
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