Ramesh Guguloth

Master in Pharmacology with over 9 years of experience in Clinical Research, Data Management, Project Management, and Biopharma Laboratory Techniques. Extensive expertise in Phase I and III patient studies (Liver Cirrhosis, Schizophrenia, and HIV Patients), biosimilar projects (PK/PD), and bioequivalence studies across multiple therapeutic areas, including diabetes, cardiovascular, CNS, antiretroviral, antibiotic, renal, and reproductive health. Proficient in laboratory techniques such as ELISA, SDS-PAGE, Western Blot, HPLC, and capillary electrophoresis, with strong knowledge of method validation and development. Skilled in regulatory audits, handling deficiencies from global authorities ( WHO, FDA, EMA etc.), and implementing process improvement initiatives. Adept at planning, scheduling, and executing projects, subject recruitment, site monitoring, protocol training, and ensuring data integrity. Strong analytical, problem-solving, and leadership skills with a commitment to delivering high-quality pharmaceutical products.

• Contributed to CDISC, QC department setup, SME programs, EDC system implementation, and Lean initiatives.
• Active participation in SQRM, MIS, IRM, SOP optimization, scientific writing programs, Change Control Board, and CRO audits.
• Led protocol training sessions for clinical sites to ensure adherence to study requirements.
• Developed subject recruitment strategies to meet study timelines and enhance predictability.
• Managed regulatory submissions and approvals, ensuring compliance with study timelines.
• Evaluated site practices for protocol adherence, escalating quality issues as necessary.
• Supported study start-up activities, including site activation and investigator onboarding.

Stamp 1G, 11/30/26