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Holistic view of Medicinal Product Development
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Preclinical / Clinical Development Strategy and Execution for early registration of new drugs, complex generics, novel biologics, biosimilars, cannabinoids, medical devices, advanced therapies and vaccines
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Innovative regulatory approach for global drug development to optimize the overall cost and accelerate timelines
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Ex-industry and ex-agency experts brought under same roof
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Consultants who have represented their drug development expertise at the Scientific advice meetings across the continents
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Early risk mitigation strategy to expedite product development process
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Thinking beyond regulatory guidelines yet achieving compliance, patient safety and ethics
Client Testimonials
Dr. Siddharth Chachad is a truly outstanding resource for us at Catawba Research and I am delighted to enthusiastically endorse him. One example of his outstanding work happened recently when we needed an extra assistance in addressing an FDA inquiry concerning an NDA we were supporting. Under high pressure to swiftly respond to the FDA's inquiry, Siddharth's ability to deliver a comprehensive and thoroughly researched document in just two days was a key component of our successful response to the inquiry. Siddharth’s commitment to excellence, rapid delivery, and profound understanding of the subject matter played a pivotal role in the overall success of our response.
Dr. Chachad’s proficiency and dedication shone brilliantly as he crafted an exceptional document that not only met but exceeded our expectations. Siddharth's professionalism and collaborative spirit were evident throughout the process. He approached the task with meticulous attention to detail, ensuring accuracy and clarity in every sentence. His adeptness at translating complex scientific concepts into showcased his exceptional communication skills.
Without a doubt, Dr. Chachad’s exceptional performance significantly contributed to our ability to meet the tight deadline and present a well-crafted response to the FDA's question. His dedication and expertise make him an invaluable asset, and I wholeheartedly recommend Siddharth for any future projects that demand excellence, precision, and an unwavering commitment to success.
Andy Silverman, PhD
CEO, Catawba Research
+1 (512) 897-8943
At Koru Lifescience, we have worked with Dr. Siddharth Chachad on multiple early-stage development programs and continue to benefit from his deep expertise in clinical and regulatory strategy. His guidance has been instrumental in shaping clear, risk-mitigated pathways for complex generics, biologics, and novel therapies.
Through Reguclin, Dr. Chachad brings a unique blend of industry and agency perspectives, offering strategic clarity and actionable insights that accelerate development timelines while maintaining regulatory rigor.
We consider Dr. Chachad a trusted partner and highly recommend him to any organization seeking experienced, forward-thinking support in global drug development.
Akhil Jain
CEO, Koru Lifescience
+64 27 882 5555
