Prashant Choudhari Email and Phone Number
"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, Analytical Methods, 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."
Idrs Labs Private Limited
View- Website:
- idrslabs.com
- Employees:
- 57
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Research AssociateIdrs Labs Private Limited Mar 2024 - PresentBengaluru, Karnataka, India -
Formulation & DevelopmentNeon Laboratories Limited Jul 2022 - Mar 2024Palghar, Maharashtra, India• 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 different formulations of Tablets, Capsules and Injections.• Compilation of trial details, Stability reports.
Prashant Choudhari Education Details
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Pharmacy -
Bharti Vidyapeeth College Of Pharmacy, KolhapurM Pharm
Frequently Asked Questions about Prashant Choudhari
What company does Prashant Choudhari work for?
Prashant Choudhari works for Idrs Labs Private Limited
What is Prashant Choudhari's role at the current company?
Prashant Choudhari's current role is Research Associate.
What schools did Prashant Choudhari attend?
Prashant Choudhari attended Shivaji University, Bharti Vidyapeeth College Of Pharmacy, Kolhapur.
Who are Prashant Choudhari's colleagues?
Prashant Choudhari's colleagues are Umapathy Appaiah, Aravind Kulkarni, Narayan Kale, Y M Sayed, Nishant Gautam, Amisha Shah, Aneeket Karmakar.
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PRASHANT CHOUDHARI
Databricks Certified Data Engineer, Azure Data Engineer, Azure Data Factory, Azure Databricks, Azure Data Lake, Azure Key Vault, Pyspark, SqlPune -
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Prashant Choudhari
Senior Devops Engineer At Hexaware Technologies Devops | Cloud | Kubernates | Aws | Terraform | CicdPune
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