Ramakrishna K — Q-Sub & Post-market Consultant (Medical Devices)

Deputy Manager - Regulatory Affairs (API)

CMC Regulatory Affairs professional with over 11 years of experience in pharmaceutical regulatory submissions. Specializes in compilation, preparation and submission of Drug Master Files (DMFs) in accordance with filing requirements of Regulatory Authorities including USFDA, EU, EDQM, TGA-Australia, TPD-Canada, WHO, KFDA, Russia, China & ROW countries. Expert in preparation of applicant part DMFs ...

Professional Overview

CMC Regulatory Affairs professional with over 11 years of experience in pharmaceutical regulatory submissions. Specializes in compilation, preparation and submission of Drug Master Files (DMFs) in accordance with filing requirements of Regulatory Authorities including USFDA, EU, EDQM, TGA-Australia,...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Regions: US, EU, APAC, MEA, CA, LATAM

Cruxi view

With over 11 years of dedicated regulatory experience, Ramakrishna K offers profound expertise in Chemistry, Manufacturing, and Controls (CMC) and Drug Master File (DMF) submissions. While rooted in the pharmaceutical sector, this skillset is uniquely valuable for medtech companies developing combination products, such as drug-eluting stents or pre-filled delivery systems. His extensive track record of successful submissions to a wide array of global authorities—including the USFDA, EU (EDQM), and Health Canada—demonstrates a mastery of complex international regulatory landscapes. This deep knowledge of API regulatory affairs and quality systems, including change control impact analysis, provides a critical and often hard-to-find competency for medtech firms navigating the dual regulatory requirements of device and drug components.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.