Regulatory & CMC Advisor
Akash is a CMC regulatory leader, having extensive experience in pharmaceutical and biologics industry for over 10 years. Akash graduated with Master of Science in Biotechnology.
Akash is a subject matter expert in CMC and regulatory compliance, health authority liaison, CTA/ NDS/ SNDS submissions, post approval life cycle management, and dossier preparation and gap assessment.
Akash successfully managed multiple regulatory submissions to Health Canada and is experience working on USFDA regulatory submissions. Akash possesses in-depth knowledge in preparing eCTD as per applicable guideline and is committed to provide strategic advice for dossier preparation and regulatory submission. He has extensive technical experience to adjudicate deficiency responses in a shorter turnaround time.
In addition to CMC and regulatory skills, Akash employs effective communication and collaboration techniques while working with the team.