Testimonials

I am happy to inform you that based the justification report provided by you, EU agency agreed for clinical waiver for injectable dossier submitted. I want to thank you for all your help and continuous support; it has been extremely helpful. Let us continue to work together for all future projects.

It was a great pleasure to work with Ramesh. I have to point out his excellent skills in managing nonclinical small and large complex multi-site in vivo studies. His thorough knowledge of toxicology combined with his pro-active and constructive character and well-organized nature enabled him to design, plan and execute the studies according to rigid timelines and to utmost success. He followed a culture of transparency regularly updating clients about their studies. His vast experience allowed him to share his thoughts about results and discuss with the clients freely and constructively. Ramesh is a quick learner and constantly seeks to broaden his knowledge on the toxicological field. As a senior member of our group, he was always a strong mentor with an urge to share his skills in a supportive and team-oriented way

As a clinical consultant working across diverse drug development programs, I’ve had the privilege of collaborating with Ramesh Subramani, whose expertise in toxicology and preclinical strategy has consistently elevated the quality and efficiency of our projects. I highly value his scientific rigour, nonclinical regulatory expertise, and collaborative mindset, which make him a trusted partner in the drug development process.

We have been working with Dr. Ramesh as a toxicology consultant for our GLP-certified laboratory projects. His expertise, reliability, and solution-oriented approach have significantly contributed to the development and international positioning of our laboratory. We value his scientific integrity and timely support across all phases of our work

Your expertise and thorough approach have been invaluable in ensuring the safety and regulatory compliance of our products. Your insights and attention to detail consistently contribute to the success of our projects

I am happy to share with you the good news of our product getting US FDA approval. The work we initiated to support qualification of impurities at higher levels was critical to our success. Your diligence to ensure the Tox studies were conducted according to Agency requirements and your inputs in the study report presentation is appreciated by our team very much

I am delighted to share our experience working with Dr. Ramesh Subramani. His exceptional expertise and support have been key to the success of our phase 3 enabling animal GLP-compliant toxicology studies. Dr. Subramani's strong background as a board-certified toxicologist and regulatory affairs professional was evident throughout the project. His strategic planning and technical knowledge ensured that every aspect of the study met the highest scientific and regulatory standards.

Dr. Subramani helped us to anticipate potential challenges and provided clear, practical advice that improved the quality and efficiency of the study. His proactive communication with our team and other stakeholders ensured smooth coordination from study design and monitoring to the final reporting stages. His guidance has also been crucial in aligning the study results with our broader regulatory goals.

Dr. Subramani's professionalism, dedication, and teamwork set a high standard. He exceeded expectations by becoming a trusted advisor and playing a pivotal role in the success of the project. I strongly recommend Dr. Subramani to any organization looking for an expert who consistently delivers excellent results in toxicology and regulatory science.

I am happy to confirm that there were no questions from the regulatory authority regarding the tox assessment report which you have provided to justify the safety at GMP facility and that they have granted the authorization immediately. Thank you again for all your support!

I am writing to you to inform you that we have efficiently defended authorities and the initially registered limit of 1500 ppm for N-nitroso compound remains as it was. No further tightening is asked with your toxicological assessment report. At this point, please let me express my gratitude for all your efforts; it was pleasure to have collaborated with you. Please note that we are considering a collaboration in near future.

I know Ramesh both personally and professionally since 19+ years. He is highly qualified and certified toxicologist that too in short span and in early phase of his industry career. He consistently demonstrated excellence in toxicology work, and he has hands on experience in various CRO and Pharmaceutical industries. His knowledge in toxicology was excellent especially in designing and conduct of safety studies for Pharmaceuticals, Biologics, Agrochemicals & Industrial chemicals etc.

Ramesh has exceptional knowledge in preclinical drug development, toxicology and expertise in regulatory submissions and addressing all regulatory concern of non-clinical toxicological evaluation. He has exemplary skill set in assessing the toxicological risk assessments and supported multiple projects for different regulatory submissions. Holds a very good rapport with colleagues from various pharmaceutical industries, interfaced with other consultants and contract research organizations to ensure a seamless execution of planned studies which is very critical for timely submissions. I am extremely delighted and always a pleasure to recommend Ramesh for safety assessment of drugs/chemicals. My best wishes for all his current and future endeavours with great success.

I have known Dr. Ramesh for over two decades and have always admired his expertise and dedication. His hands-on experience in conducting diverse regulatory toxicology studies, adhering to GLP standards, has been invaluable during his tenure at CROs. Additionally, his proficiency in planning and preparing study designs, monitoring studies, compiling dossiers, and responding to regulatory queries was further honed while working with a pharmaceutical manufacturing company. This rich and well-rounded experience makes him exceptionally skilled in the services he provides through his consultancy initiative. His deep knowledge, strong work ethic, disciplined approach, and positive attitude make him one of the most reliable professionals in the field of regulatory consultancy. I wholeheartedly wish him all the best in his endeavours.

When planning, organising and monitoring in-vivo and also in-vitro OECD Guideline studies (skin and eye irritation and corrosion), Ramesh has provided a truly excellent service, together with his Indian partner CROs and external experimental toxicology and regulatory affairs experts. Other than with most, merely "Western", consulting or laboratory businesses, both cost and promised timelines had not been extended. All this had happened with a professional, but at the same time unusually friendly mindset, comprehensive yet effective communication and ending up with flawless reporting. Thanks a lot Ramesh! Highly recommended, really!

It has been an absolute pleasure working with Dr. Ramesh Subramani. His deep expertise in toxicology has been invaluable in seamlessly guiding our clients and our internal safety assessments and regulatory submissions. We continue to rely on his insightful advice to navigate any challenges with confidence. Dr. Ramesh is a trusted partner and a true asset in the field of regulatory toxicology. Highly recommend and look forward to continued collaborations with him.

We were working on a critical first-to-market injectables product in our portfolio. As part of the requirement from the FDA, we had to qualify one of the impurities at a higher level through a Tox study. Dr. Ramesh Subramani provided us the expert advice and support by working with our study partner. He ensured that the study protocol was designed appropriately, oversaw the work that was executed, and reviewed and authored the report. The FDA did not have any comments on our justification and submission, and we got the approval on time, a testament to the quality of work product from Dr. Subramani. I highly recommend Dr. Ramesh Subramani as a consultant for the services he provides.