Herbal Clinical Trials
Food Research Lab(FRL) Regulatory Expertise and Clinical Trials Support for Herbals
Food Research Lab(FRL) Regulatory Expertise and Clinical Trials Support for Herbals
Looking to pioneer new herbal clinical trials or customize existing ones to meet specific research goals? Seeking creative approaches to promote your brand in the herbal and clinical research industry?
At FRL, we have an extensive experience in Herbal and Ayurvedic research, coupled with a state-of-the-art research facility. We offer a diverse range of cost-effective and customized preclinical and clinical research services designed to validate the efficacy and safety of raw materials and formulations, all in strict compliance with regulatory requirements for Herbal medicines (including indigenous herbal medicines, herbal medicines in systems (Ayurveda, Unani, and Siddha), modified herbal medicines and imported products with a herbal medicine base herbal medicines are prescribed by physicians). We offer following services
For herbal remedies, our Phase 1 studies are designed to determine the Maximum Tolerated Dose (MTD) and provide early measurements of drug activity. Safety and efficacy are our top priorities at this crucial stage.
In cases where there are reports of potential toxicity or when the herbal preparation is intended for use beyond three months, we conduct comprehensive toxicity studies. These studies, spanning 4-6 weeks and involving two species, are essential for Phase 2 and Phase 3 trials, ensuring the safety of the interventions.
Our experienced team, synonymous with excellence, holds an intricate understanding of the complex regulatory framework governing health research. We specialize in the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy (AYUSH) regulations in India. We have successfully guided numerous clinical trials and regulatory submissions through the meticulous scrutiny of the AYUSH, India, South Korea MFDS, USA, and EU authorities, achieving approvals and recognition.
Our dedicated operations team operates with precision and diligence, comprehending the far-reaching implications of every action and decision taken during the regulatory process. When you entrust your clinical study or regulatory submission to FRL, you can rest assured that it is in the hands of seasoned experts who understand the nuances of compliance, safety, and efficacy standards. We follow WHO Operational guidelines and compliance with good manufacturing practice, GMP regarding regulatory requirements needed to support clinical trials of herbal products.
We seamlessly bridge the gap between global health research and local regulatory requirements. Our comprehensive approach ensures that your herbal based clinical trials align with international standards while meeting the specific demands of each regulatory authority.
FRL places the highest importance on ethical guidelines governing biomedical research. We strictly adhere to patient information, informed consent, and the protection of vulnerable populations. Our commitment to ethical standards is unwavering.
We understand the significance of gaining scientific and ethical approval for clinical trials. Our team ensures that all trials are approved by the appropriate scientific and ethical committees of the concerned institutes, upholding the highest standards of transparency and accountability.
FRL believes in collaborative excellence. We ensure that competent Ayurvedic, Siddha, or Unani physicians are actively involved as co-investigators in clinical trials, bringing a wealth of traditional knowledge and expertise to the research process.
As an ISO 9001:2008 certified and Department of AYUSH approved facility, FRL is committed to delivering time-bound quality testing services for raw materials and finished products. Our unwavering dedication to upholding rigorous quality standards sets us apart.
Partner with FRL for ethical, compliant, and pioneering clinical trials. Together, we’ll advance the frontiers of herbal and nutraceutical research while upholding the values of safety, efficacy, and patient well-being. Contact us today to embark on a journey of discovery and innovation.
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