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About Us
At Auxochromofours, we are a leading provider of regulatory services, dedicated to helping businesses navigate the intricate world of regulations and compliance. With a team of seasoned professionals, we bring unmatched expertise across a wide range of sectors, including discovery research, nonclinical services, product safety, and market authorization. Our mission is to empower organizations to achieve compliance seamlessly, enabling them to focus on innovation and growth. Trust AUXO to be your partner in overcoming regulatory challenges and driving success in your industry.
AUXO's Experience
With over 18+ years expertise, AUXO and its expert team specialise in toxicology, SEND services, computer system validation and in-vitro research services. Backed by deep scientific knowledge and global experience, we deliver accurate, high-quality solutions to ensure client success and regulatory excellence.
Projects Delivered
At AUXO, we take pride in delivering high-quality, regulatory-compliant projects with unmatched precision and efficiency. Our expert team has successfully completed over 3,000 HBEL reports in just 36 months, alongside a wide range of services including, genotoxicity, medical device assessments, cosmetic product safety assessments, nitrosamine, extractables & leachables assessments, impurity qualifications, toxicology profiling, SEND data submissions, computer system validations and in-vitro research services. Every project is meticulously validated, rigorously reviewed, and aligned with global regulatory standards to ensure accuracy and compliance. With a client-first approach, we provide timely deliveries, transparent methodologies, and dependable solutions, empowering pharmaceutical, life sciences, and related industries to achieve their regulatory and safety objectives with confidence.
Meet our team
Basavaraj H C
Co- Founder & Director
Dr. Ganesh Nanjappa
Advisor
Dr. Rutuja Burji
Advisor
Dr. Khalid Imran
Head - Innovations
Shreyas M Burji
Co- Founder & Director
Dr. Gowraganahalli Jagadeesh
Advisor - Former FDA
Dr. Lakshminarayana M
Director - Regulatory & Toxicology
Licenses & Certificates
MSME
Drugs Control Department
Pollution Control Board Karnataka
ISO 9001:2015
FAQ's
We deliver end-to-end regulatory compliance solutions for the pharmaceutical and healthcare industries, with core expertise in toxicology risk assessment and SEND services. Our toxicology assessments ensure that products meet global safety standards, while our SEND support enables accurate, compliant data submissions to regulatory authorities. With a science-driven and regulatory-focused approach, we enable our clients to achieve compliance efficiently while safeguarding patient safety and accelatering market access.
We support toxicology risk assessment by evaluating the safety of pharmaceutical ingredients, excipients, and medical products through rigorous scientific review and regulatory-aligned methodologies. Our team conducts hazard identification, does-response analysis, and exposure assessments, providing well-documented toxicology reports that meet global regulatory standards. This helps clients demponstrate product safety, address regulatory queries, and mitigate potential risks early in development.
For SEND data conversion, we provide end-to-end support in transforming preclinical study data into fully complaint Standard for Exchange of Nonclinical Data (SEND) format. Our services include dataset mapping, validation, and quality control to ensure accuracy, consistency, and readiness for regulatory submissions. By streamlining SEND conversions, we help clients reduce delays, avoid costly rework, and achieve faster acceptance by agencies such as the FDA.
Yes, we provide full support for regulatory submissions and market authorization in the pharmaceutical and healthcare sectors. Our team assists in preparing, reviewing, and submitting regulatory dossiers in formats such as eCTD?CTD for global markets, including INDs, NDAs,ANDs, and clinical trial applications. We also guide clients through marketing authorization processes, ensuring alignment with regional regulatory requirements(FDA, EMA, CDSCO, MHRA, and others). From regulatory strategy development and gap analysis to dossier compilation. responses to agency queries, and lifecycle management, we help stramline submissions, reduce approval timelines, and secure timely market access.
We specialize in serving the pharmaceutical, biotechnology, medical device, agricultural products and healthcare industries, with particular expertise in areas such as toxicology and regulatory data standards (SEND). Our team also supports organizations in adjacent sectors including contract research organizations (CROs), clinical laboratories, and life sciences technology providers, helping them navigate complex regulatory requirements. By combining scientific depth with regulatory requirements. By combining scientific depth with regulatory insight, we deliver tailored compliance solutios that ensure safety, quality, and accelerated market access.