Prashant Choudhari
Research Associate
- Role
- Research Associate at IDRS LABS PRIVATE LIMITED
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Prashant Choudhari
As a Formulation and Development Scientist with a strong interest in Regulatory Affairs, I have experience in designing and optimizing drug formulations while maintaining compliance with regulatory requirements. I have a strong understanding of regulatory guidelines from global regulatory agencies, ICH, and I am familiar with the drug development process from pre-clinical to post-approval stages. I have successfully collaborated with cross-functional teams to develop innovative formulations that meet regulatory and commercial requirements. In addition, I have experience in preparing regulatory documents, such as Batch Manufacturing Records(BMR), Specifications, Stability Data, Protocol, PDR and have a strong attention to detail in ensuring these documents meet regulatory requirements. I am now seeking a role in Regulatory Affairs to further develop my regulatory knowledge and contribute to the development and submission of regulatory documents for drug products. I am excited to leverage my knowledge and experience to contribute to the success of a dynamic organization in the pharmaceuticals.\"
Experience
Research Associate
Mar 2024 — Present · Bengaluru, IN
Practice of Literature search, Patent search, Data compilation, Data analysis, Preformulation studies, Innovator sample evaluation.• Preparation of documents such as Stability protocol, Product Development Report (PDR), Trial Batch Reports (TBR), Bill of Material (BOM), Master formula records (MFR).• Knowledge of manufacturing documents like Batch Manufacturing Records (BMR), Specifications, Analytical Methods, Stability Data• Resolving regulatory query, To review Artwork and Data Sheets (DS).• Knowledge of Clinical Trial Phases, Product Development and Drug Development Process, Acquainted with ICH Guidelines,• To Prepare and perform Hold time study protocol, In use study protocol, Compatibility study protocol and report for the same. • To Execute Trials, Stress batches & Stability batches of formulations of Injections.• Compilation of trial details, Stability reports.
Education
Bharti Vidyapeeth College of Pharmacy, Kolhapur
M Pharm
Shivaji University
Bachelor of Pharmacy - BPharm
2015 — 2019
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