Pavani Krishna Kumari Karitla

To work in an environment, which is an innovative, challenging and which offers a profound knowledge base to enhance my talent, exposure and zeal of learning.

• Well versed in fulfilling the documentation requirements and quality guidelines from various regulatory agencies FDA& EDQM.
• Compilation of USDMFs as per GDUFA requirements in eCTD format.
• Compilation of Annual reports and Amendments to USFDA.
• Preparation and Submission of Renewals/Revision of CEP`s to EDQM and updating as when changes are made.
• Submission of DMFs (in eCTD format) to USFDA through Electronic Submission Gateway (ESG).
• Using the software like Pharmaready and Lorenz eValidator to compile DMFs in eCTD format.
• Hands on experience on preparation of drug master files & life cycle management.
• Handling of customer Queries.
• Review of specifications and test procedure of drug substance as per the pharmacopeia.
• Review and assessment of change controls and providing guidance to the team on proposed changes.
• Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.
• Reviewing the documents received from various departments, QA, QC, R&D and Production to minimize the errors at the time of submission to regulatory agencies.
• Evaluation of Product profile and preparation of critical quality attributes (CQAs).
• Good understanding and interpretation skills.

• English
• Hindi
• Telugu

• Father's Name: Karitla Nooka Ramana
• Date of Birth: 06/29/99
• Gender: Female
• Marital Status: Unmarried

I hereby declare that the above-mentioned information is correct up to my knowledge and belief and I bear the responsibility for the correctness of the above-mentioned particulars.