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"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."

"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. I highly recommend Srilekha for any future projects. Her deep knowledge of product development, regulatory compliance, and her professionalism makes her an asset to any organization."

"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, and 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."

“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.”

“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.”

“Sri can do what many otherwise skilled regulatory experts cannot - knit together strategic interests with her deep scientific acumen to lead a team through successful regulatory filings and communications. Sri is my new standard for how a regulatory function should work in your company.”

“It has been a pleasure working with Sri for our regulatory needs.  Sri’s professionalism, insight, and rapid responsiveness were just what we needed.  I worked with Sri on a novel pathology diagnostic product for which we took the De Novo pathway.  Being the first to submit to a new regulatory space comes with a lot of uncertainty.  Sri’s knowledge, guidance, and leadership was a major contributor to the strength of our Pre-submission and provided us with confidence as we moved through the program.  Furthermore, her dependability and exemplary rapport building set the perfect foundation to model our path to success.  Our team will continue to use Script Molecular for this and other regulatory consulting needs.”

"We began work with Sri pre-money and she kindly helped advise us on our regulatory strategy for a IVD test we were planning. She was included as a part of our now successful NIH funding for an SBIR Direct-to-Phase II award. Her extensive, previous expertise in molecular diagnostic test approvals through the FDA are a big plus. Personally, she is kind and easy to work with and very familiar with navigating the FDA systems."

"It’s been such a pleasure getting to know Dr. Srilekha Deka — a remarkable scientist, leader, and founder who brings both deep technical expertise and inspiring vision to everything she does.

What stands out most about Srilekha is how she blends scientific precision with entrepreneurial courage. Through her company, Script Molecular, she’s built a consulting practice that truly fills a critical gap in the biotech and medical device world. She’s helping innovators navigate the complex path from concept to market — improving quality, ensuring regulatory readiness, and accelerating product development with a level of insight and care that few can match.

Her background in microbiology, immunology, and molecular diagnostics gives her a unique ability to bridge science and business. She’s as comfortable discussing FDA strategy as she is guiding technical teams through complex assay development or process transfer challenges.

More than anything, Srilekha is collaborative, authentic, and mission-driven. She genuinely wants to see her clients and colleagues succeed — and it shows in the trust and respect she’s earned across the industry.

I’m so excited to see the continued growth of Script Molecular under her leadership and have no doubt that Srilekha will continue to make a lasting impact on the life science community."

Working with Sri on our De Novo product and IVD reagent kit was an outstanding experience. She brought a high level of regulatory expertise, strategic insight, and professionalism to the project from start to finish.

What I appreciated most was her ability to not only provide regulatory guidance, but to actively lead the process forward with confidence and clarity. She consistently delivered on time, anticipated potential risks before they became issues, and provided practical next steps that kept the project moving efficiently. Her recommendations were thoughtful, well supported, and clearly based on deep experience in the regulatory space.

It was also very apparent that she had significant experience interacting directly with FDA review teams and understood what would be expected throughout the process. We completed two successful pre-subs together, with the first being particularly challenging due to the De Novo nature of the product. The way she communicated with the FDA demonstrated both credibility and confidence, and many of her proposed approaches were accepted with minimal resistance. That level of preparation and insight added tremendous value to our program and helped streamline interactions with the agency.

She was never hesitant to share her expert opinion or propose solutions when challenges arose, which made her an invaluable partner throughout the submission process. Her collaborative approach, reliability, and ability to navigate complex regulatory pathways gave our team confidence at every stage.

I would gladly work with her again and greatly value the expertise and leadership she brought to our program.