Rajasekhar Attuluri Email & Phone Number

India

Labeling expert for US market

Hyderabad, Telangana, India

• Good knowledge in US Labeling preparation and handled multiple private label distributor Labeling.
• Preparation, review and compilation of Module-I (Administrative/Labeling section) in e-CTD format and complying the labeling with 21 CFR 201.
• Monitoring of Drugs@fda website for latest updates/revisions in the RLD (reference listed drug) package inserts.
• Preparation and review of container, carton label and package inserts. Experience in preparing required documents to the CBE-0 submissions.
• Preparation and review of private label distributors labeling.
• Review, Submission of SPLs content labeling in XML format to FDA and Drug Listings to Office of Compliance to publish in Dailymed.

Hyderabad, Telangana, India

• Preparation & Review of Registration Dossiers as per European Union requirements (In CTD format).
• Filing of Registration dossier through National, Decentralized and Mutual recognition procedures in various EU countries.
• Preparation of electronic format of CTD for E-submission in various EU Medicinal agencies.
• Liaison with various departments like R&D, Analytical Development, QC, QA, Production and Corporate affairs.
• Review of various documents such as Product development reports, Batch manufacturing records, Change controls, Stability protocols, Validation protocols and Validation reports of process as well as Specifications and.
• Preparation & Review of tailor made customer specific Dossiers.

Hyderabad, Telangana, India

• Supervision of manufacturing, packing of different dosage forms like tablets, capsules, syrups, ointments, creams.
• Maintenance of records of batch manufacturing and packing