Suvi Neelam Email & Phone Number

Auckland, New Zealand

Auckland, New Zealand

• Decontamination of materials
• Printing labels and batch documents
• Compounding/mixing product in the cleanroom
• Checking, packing, and labelling final product
• Ensuring completion of documentation
• An eye for detail and meticulous record-keeping skills

Mumbai, Maharashtra, India

I feel great pleasure making myself Freelancer and providing my services to individuals, institutions and organizations with respect to Regulatory affairs.I have been involved with all aspects of regulatory affairs activities from Dossier compilation to all regulatory activities involved in the life cycle management of pharmaceutical medicinal products. I.

Mumbai Area, India

• Preparation, Review & compilation of dossiers for submission to regulatory body.
• Preparation of dossiers in CTD, ACTD format & countries specific format as per the current guidelines for the Asia pacific & African countries.
• Preparation of legal documents required for registration as per countries requirement, for example. CPP, FSC. GMP, ML, POA SLSPP certificate, etc.
• Update & submit all products information’s (SmPCs, PIL’s & artworks for package labelling).
• Timely processing and compilation of regulatory information in accordance with requirements & regulations in ROW market to ensure high quality regulatory submissions.
• Synchronize with various departments (production, quality control, and quality assurance, R & D, F&D) to collect required input for timely regulatory submission of products.

Mumbai Area, India

- Vendor qualification & evaluation – R/M & P/M- To review and approve the Vendor questionnaire documents.- To provide the technical data of Vendor Qualification during Plant audit.- Co-ordination with other Departments like Production, QC, purchase dept. and regulatory affairs dept., AMD &PDR dept.- To monitor the routine Enterprise Resources Planning.

Post Graduation In Regulatory Affairs

Bachelor Of Pharmacy - Bpharm