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.

Arun is an accomplished professional with over 20+ years of experience in the field of Clinical Research, specializing in Audits, QMS,  hosting inspections, and Scientific & Regulatory writing. 

His journey in the Research and Development career started at Torrent Research Centre in Ahmedabad, India, where he honed his skills and developed a keen interest in Clinical Pharmacology. Later on, he served at Ranbaxy Pharma, New Delhi-Noida between 2004-2006 as a Research Scientist in Clinical Pharmacology Unit, where he further expanded his knowledge and expertise in the field.

Arun's experience led him to join the CRO industry, where he worked as a Quality Assurance professional for more than 14 years. He worked with renowned companies such as Ecron Acunova/Navitas Lifesciences and Quintiles (IQVIA), Bengaluru. His experience in the industry allowed him to develop a comprehensive understanding of the Clinical Research process, and he played a vital role in ensuring that the highest quality standards were met in each project.

Apart from his professional achievements, Arun is also a passionate teacher. He served as a teaching faculty at Manipal College of Pharmaceutical Sciences while pursuing his PhD at MCOPS (MAHE). 

Dr. Girish BV is a highly accomplished pharmaceutical scientist with over 21 years of experience leading and executing analytical research in the pharmaceutical development domain. He holds a Ph.D. in Chemistry. Has a proven track record of successfully evolving and leading research and development departments. His expertise encompasses a wide range of activities including Dossier, Application Research projects and Quality Management. Dr. Girish has a distinguished career spanning more than two decades, holding leadership positions at various pharmaceutical companies in India. His most recent role was as Senior Group Leader at SPI Pharma Inc., India branch. 

Technical Proficiency

Dr. Girish possesses a deep understanding of analytical techniques critical for pharmaceutical development and materials characterization. He is proficient in a wide array of methodologies including

• HPLC (High-Performance Liquid Chromatography)

• Dissolution Testing

• GC (Gas Chromatography)

• Titrimetry

• SEM (Scanning Electron Microscopy)

• DSC (Differential Scanning Calorimetry)

• SSA (Specific Surface Area)

• TEM (Transmission Electron Microscopy)

• PSD (Particle Size Distribution)

• XRD (X-ray Diffraction)

• Taste Evaluation Studies

• Rheology

He leverages his expertise to develop, Transfer, troubleshoot, and validate analytical methods according to regulatory requirements. Dr. Girish is also well-versed in the application of AQbD (Quality by Design) principles within the pharmaceutical development domain process.

Dosage form Knowledge

Dr. Girish possesses extensive knowledge of various dosage forms, including:

• Orally Disintegrating Tablets (ODT)

• Orally Disintegrating Powders (ODP)

• Swallow Tablets

• Modified Release Dosage Forms

• Sublingual Dosage Forms

• Soft gelatin Capsules