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QDraft Services LLP
QDraft Services LLP
QDraft Services LLP is a customized and innovative professional services provider, caters to the needs of clinical organizations seeking to perform Independent audits, technical reviews of their GxP reports and documentation and enhance their quality management systems.
The company is co-founded by Arun Theerthahalli, M.Pharm PhD., an accomplished industry professional with a proven track record of excellence in Clinical Research.
QDraft empowers Pharma and Clinical research organizations to navigate regulatory requirements and achieve their goals. QDraft offers expertise in audits (Clinical, Bioanalytical, IT policies and CSV for GxP systems), QMS, training, eCTD review, technical and data integrity review of study data and reports, ensuring compliance and efficiency throughout the clinical research process
QDraft specializes in designing quality management systems that enable clinical organizations to meet the needs and expectations of their customers, accreditation bodies and regulatory agencies. With in-depth understanding of industry standards and best practices
QDraft offers tailored solutions that are specific to each client's unique requirements and goals.
Clinical Development Quality - Commitment, Compliance, and Innovation
We bring over two decades of expertise in Clinical Research, with a strong focus on Quality Management Systems (QMS), audits, regulatory compliance, and scientific and regulatory writing. Our experience spans the entire research and development lifecycle, including clinical pharmacology, hosting inspections, and ensuring adherence to global standards.
With extensive exposure to both research organizations and the CRO industry, we have developed a deep understanding of clinical processes and quality assurance practices. Our team has successfully partnered with leading pharmaceutical and life sciences companies, driving excellence in project execution and regulatory compliance.
Beyond industry operations, we are committed to knowledge sharing and capacity building through academic collaborations and training initiatives. This blend of technical proficiency, regulatory insight, and educational engagement positions us as a trusted partner in advancing clinical research and quality standards.
Innovating Through Formulation and Analytical Excellence
We specialize in advanced formulation development and analytical sciences, delivering robust solutions that meet global quality and regulatory standards. Our expertise spans the entire product lifecycle - from pre-formulation studies and method development to stability testing and validation. With a strong foundation in pharmaceutical sciences, we ensure precision, consistency, and compliance in every process.
Our technical capabilities include designing optimized formulations, developing validated analytical methods, and implementing stringent quality control measures. By leveraging cutting-edge technologies and scientific rigor, we enable efficient product development and regulatory submissions, ensuring safety, efficacy, and reliability.
Technical Proficiency
Our Experts possesses a deep understanding of analytical techniques critical for pharmaceutical development and materials characterization. He is proficient in a wide array of methodologies including
We levarage our expertise to develop, Transfer, troubleshoot, and validate analytical methods according to regulatory requirements. Our Experts are well-versed in the application of AQbD (Quality by Design) principles within the pharmaceutical development domain process.
QDraft Services LLP
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