Herbal Clinical Trials

Food Research Lab(FRL) Regulatory Expertise and Clinical Trials Support for Herbals

Herbal Clinical Trials

Food Research Lab (FRL) CRO: Create clinically proven product claims to support your skincare, cosmetic, or personal care brand, and show that your products work and are safe to use.

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

  • Physicochemical Analysis: We conduct comprehensive physicochemical analyses, including ash values, moisture content, minerals content, and extractive values, ensuring the highest quality standards.
  • Fluorescence Analysis: Our experts employ advanced techniques for precise fluorescence analysis.
  • Microscopic Study: We delve deep into microscopic studies, including tissue structure (TS), powder study, veinlets, vein termination, and stomatal index evaluations.
  • HPTLC and HPLC FingerprintingFRL utilizes state-of-the-art HPTLC and HPLC fingerprinting for accurate phytochemical profiling.
  • GCMS Library Data: Our extensive GCMS library data aids in the identification and characterization of phytoconstituents.
  • Extraction and Analysis: We employ diverse extraction methods and conduct in-depth phytochemical analyses.
  • Isolation and Characterization FRL specializes in the isolation and characterization of phytoconstituents.
  • Bioassay-Guided Isolation: We offer bioassay-guided isolation and characterization for specific activities such as diabetes management, antioxidants, and antimicrobial properties.
  • Phase 1 Studies for Safety and Activity Assessment:

    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.

    Toxicity Assessment for Informed Phase 2 and Phase 3 Trials:

    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.

  • • Efficacy Studies: FRL conducts efficacy studies, both in vitro and in vivo, across various domains, including cancer, diabetes, immunomodulation, hepatoprotection, obesity management, and anti-infective therapies.
  • • Antioxidant Studies: We assess the antioxidant potential of compounds and formulations.
  • • Toxicology Studies: Our services encompass a wide range of toxicology studies, including acute oral toxicity, dermal toxicity, ocular toxicity, inhalation toxicity, repeat-dose toxicity studies, skin sensitization, genotoxicity, AMES tests, and chromosomal aberration studies.
  • Feasibility and Regulatory Approvals: FRL assists in navigating the complexities of feasibility studies and obtaining regulatory approvals.
  • Medical Writing: Our team provides expert medical writing services for clinical research documentation.
  • Project Management: We offer project management solutions to streamline your clinical research initiatives.
  • Clinical Trial and Site Management: FRL excels in clinical trial and site management, ensuring the seamless execution of research projects.
  • Clinical Trial Monitoring: Our dedicated team conducts thorough clinical trial monitoring to maintain data integrity.
  • Clinical Data Management: We provide comprehensive clinical data management solutions.
  • Biostatistics: FRL offers biostatistical expertise to analyze and interpret clinical data effectively.
  • 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.

    Scientific and Ethical Approval:

    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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