K Prasad Email & Phone Number

Hyderabad, Telangana, India

Responsible for high Quality Regulatory submissions to global agencies.

Hyderabad Area, India

Ensure High Quality Regulatory submissions to various regions (USA, Canada and EU ) Products regulatory filing strategy review and approval.Ensure life cycle management for submission products.Identify potential deficiencies in documents and suggest action plans to meet regulatory requirements.Provide response to Regulatory and customer queries within timelines.Assessment and setting of limits for Genotoxic impurities and residual metal catalysts in drug substances. Change control system; review of effectiveness of changes in the process, facility and procedures, assessing the changes w.r.t the DMF commitments, further updation with authorities.Provide training and ensure adequate job knowledge to team members to fulfill assigned tasks.

Hyderabad Area, India

Ensure High Quality Regulatory submissions to various regions (USA, Canada, EU and Japan) Products regulatory filing strategy review and guidance to team.USP/EP/BP Monograph development and assessment for in-house products.Propose revisions for monographs with technical justifications.Ensure life cycle management for submission products.Identify potential deficiencies in documents and suggest action plans to meet regulatory requirements.Provide response to Regulatory and customer queries within timelines.Review and approval of validations (process and analytical methods), verification reports for compendial methods.Assessment and setting of limits for Genotoxic impurities and residual metal catalysts in drug substances. Change control system; review of effectiveness of changes in the process, facility and procedures, assessing the changes w.r.t the DMF commitments, further updation with authorities.Ensure Regulatory compliance for the product filed with Authorities and Customers.

-Compilation of DS modules as per eCTD requirement.-Review of documents related to DS for submission.-Compilation of AR/Amendments.-Review of Changes w.r.t submissions

-Coordinating product technology transfer & review of development documentation [Design input, process feasibility, optimization, holding studies. Etc] and addressing issues and involvement further rectification with corrective actions.-Review and approval of validation protocol and reports [process, procedure and system] and online monitoring of Validation studies in the plant for effective implementation of protocols.-Online monitoring of the process quality parameters [review of impurity levels] and ensuring the consistency of quality of the products.

M.Sc, Chemistry

B.Scv, Maths, First