Testimonials
“Working with Srilekha Deka of Script Molecular has been an exceptional experience. Srilekha brings a collaborative spirit and deep regulatory expertise. We created a highly effective partnership successfully supporting a client in navigating the complex regulatory landscape and designing various studies for the clearance of an innovative pathology imaging device. I highly recommend Srilekha to any organization seeking expert guidance on FDA interactions.”
Neil R. Mucci
Founder & CEO, Global BioClinical, Seattle, WA
“I am pleased to recommend Dr. Srilekha Deka, who served as a consultant for Molecular Designs (MLD) on the development of our first in vitro diagnostic (IVD) product. Srilekha’s expertise in IVD product development and regulatory compliance was invaluable throughout the project.
Srilekha’s years of experience in the field were evident as she seamlessly merged the technical aspects of product development with quality and regulatory compliance. With her proficiency in development and commercialization of IVD medical devices, she guided us through key stages of product design, feasibility, and validation under Design Control (21 CFR 820.30). She ensured that our product met FDA regulations and ISO 13485:2016 standards, while also managing risk, verification/validation processes, and software validations. Her innovative problem-solving helped us avoid costly delays and stay on track.
Srilekha’s collaborative approach made her easy to work with, whether independently or with cross-functional teams. What stands out most about Srilekha is her ability to work as a trusted partner and a team member. Her clear communication and leadership helped us meet critical deadlines and achieve design lock, enabling us to start clinical trials confidently and on time.
I highly recommend Srilekha for any future projects. Her deep knowledge of product development, regulatory compliance, and her professionalism make her an asset to any organization.”
Morgan Porter
Chief Operations Officer, Molecular Designs LLC, Birmingham, AL
“Sri has been an invaluable partner in shaping our U.S. strategy at Rosalind Dx. She guided us through the complexities of U.S. regulatory pathways and reimbursement, helping us crystallize our commercialization strategy. Sri also developed clear, concise materials - including a white paper and one-pager - which were data-room ready. She is deeply knowledgeable, articulate, and consistently delivers high-quality work on time and on point. Her support has been instrumental in positioning us for success with both investors and the U.S. market.”
Ella Fung, Ph.D.
Co-Founder & CEO, Rosalind Dx, Singapore
“Sri Deka provided valuable support to AmplifiDx as we developed our Design History File, contributing clear, well-structured templates and documentation. Her combination of regulatory, quality, and product development experience made her input practical and easy to integrate into our existing systems.”
Nancy Schoenbrunner
CEO, AmplifiDx, Boston, MA
“Our technical team received several quality and regulatory training sessions from Script Molecular Inc. that were invaluable to our progress. They shared their experience, as it related to our work, in a way that was understandable and actionable. We will continue to work with their team, and highly recommend them to those involved in the development of a regulated product”