Shalu Singh

Pharmacokinetics (PK) Scientist with expertise in BA/BE and clinical study design across Phase I–III trials. Experienced in protocol review, PK write-ups, and scientific feasibility assessments. Strong in PK data analysis, AUC interpretation, and regulatory-compliant reporting. Skilled at coordinating with sponsors and cross-functional teams for smooth study execution. Committed to delivering accurate, high-quality clinical documentation and scientific support.

Technical Officer (Pharmacokinetics) - Lambda Therapeutic Research Ltd

• Provide scientific and technical feasibility assessments for BA/BE and Clinical Trial study designs across multiple product categories.
• Act as a primary scientific interface with internal departments and external stakeholders to address sponsor queries and ensure technically sound study execution.
• Deliver pharmacokinetic (PK) expertise in the design and development of BA/BE and clinical study protocols.
• Review and critically evaluate PK components of BA/BE, Phase I, II, and III protocols and clinical study reports.
• Conduct comprehensive literature reviews to support clinical study design, interpretation, and regulatory justification.
• Contribute scientific inputs to the Comprehensive Summary of Bioequivalence (CS-BE) reports.
• Lead and support technical and regulatory discussions with sponsors, providing scientifically justified responses to study and regulatory queries.
• Perform PK meta-analyses and advanced data analyses to support complex formulations and assess regulatory acceptability.
• Review preliminary clinical study results and correlate outcomes with historical data and published literature, ensuring regulatory compliance across global submissions.
• Prepare PK interpretations aligned with approved protocols, SOPs, and international regulatory guidelines.
• Conduct in-silico modeling and simulations, including IVIVC, Population PK analysis, and other modeling approaches to support clinical development strategies.
• Ensure all activities comply with OECD GLP principles, maintaining high standards of quality and regulatory adherence.

Internship in production Department - Globela pharma pvt.Ltd

(2022 - 2022)

Internship as a Pharmacist - Shunsine global hospital

(2022 - 2022)

Trainee Technical Assistant - Torrent pharmaceutical

(2023 - 2023)

Masters in Pharmacy - Pharmacology - Parul University (2023 - 2025)

Bachelors in pharmacy - Maliba Pharmacy College (2019 - 2023)

H.S.C (2019 - 2019)

S.S.C (2016 - 2016)