Deepali Hande Email & Phone Number

Mumbai, Maharashtra, India

Mumbai Area, India

Navi-Mumbai

• Preparation of dossiers for different dosage forms for Europe, ANDA Countries (eCTD & CTD). • Successfully handled a variety of major submissions in stringent timelines while maintain the quality of dossiers.• Involved in responding of queries raised by regulatory agencies.• Involved in co-ordination with Plant, R&D and QA-QC Department for receiving and reviewing of Documents.• Review the documents like Batch Manufacturing Records, Batch Packing Records (Executed and commercial), Process development report, Specifications, Test procedures, process validation protocols and Reports, Analytical method validations, Certificate of analysis, Stability protocols, Stability data, packaging Specification & Artworks.

Mumbai Area, India

• Preparation & submission of dossiers for the European countries, CIS, Asian & African Market (eCTD, CTD & ACTD).• Successfully handled a variety of major submissions in very strict timelines while maintain the quality of dossiers.• Involved in responding of queries raised by regulatory agencies.• Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving of Documents• Reviewed the documents like Batch Manufacturing Records, Batch Packing Records (Executed and commercial), Process development report, specifications, test procedures, process validation protocols (Pre-process validations, cleaning validations), Analytical method validations, Certificate of analysis, Stability protocols, Stability data and Packaging Specification & Artworks.

Mumbai Area, India

• Compilation & submission of dossiers for the African Market (CTD).• Reviewed the documents like Batch Manufacturing Records, Batch Packing Records (Executed and commercial), Process development report, specifications, test procedures, process validation protocols (Pre-process validations, cleaning validations), Analytical method validations, Certificate of analysis, Stability protocols, Stability data and Packaging Specification & Artworks.• Preparation of COAs (Pharmaceutical) for Export.• Preparation & approval of SOP's• Documentation of Quality assurance department including preparation BMR, preparation of SOP, maintaining of documents of CAPA, handling Validation part of Autoclave, Tunnel, Cold storage, Deep Fridge & Area validation and also maintaining records of IQ, OQ, PQ, Handling training sessions & training documents.• And also documentation part of Quality control departement like COA Preparation, keeping record of leak test, TOC. • Documents of COPP, Licensing related documents.