Rani Sabhavat
I’m a Biochemist with several years in QA and Regulatory Affairs in the pharmaceutical industry. Leads teams in fast paced environments to ensure all global regulatory strategies, implementation, and quality standards are met across the company. Head of operations, manages teams and trains staff to maintain company-wide knowledge of regulatory compliance. Generates regulatory filings, manufacturing license approvals, and responds to regulatory agency inquiries. Maintains audit-readiness at all times.
I have generated all regulatory updates with FDA, EMEA, and KDMF, Health Canada DMF and keep the drug master file updated. Manage R & D, QC, QA, production, regulatory teams, and new product development. Skilled in DMF submissions, amendments, supplements and annual report for CTD/eCTD. Working knowledge of 21 CFR parts 11, 210, 211, 312, 314, 820, cGMPs, GCPs, ISO 13485, FDA, ICH, PICs’s code of GMP and EU regulation. • Proficiency with US and EU medical devices classification and US regulatory approval procedures ( 510(k), denovo and PMA) I have global regulatory expert skills in dossier preparation, review and submission, variation packages (pre-approval & post approval), Post approval changes to USA, TGA Europe and Global markets as assist to product life cycle management. I have experience in preparing, review and manage timely preparation of drug substance a in the area of CMC sections in format of eCTD, CTD and country specific format for supports to marketing approval and product maintenance according to regulatory guidelines. Co-ordination with country clients (initiation to submit the application forms, invitation letters & agenda etc) for inviting the regulatory authority to inspect the facility. Review of change controls and evaluate the impact to product quality and notify to respective health Authority in format of country specific variation package. Reviewing of internal documents as part of dossiers and queries i.e upstream, downstream batch records & biosimilarity report for DS, Batch filing & Batch packing records for DP.
Core Competencies: Chemistry, Manufacturing & Controls | Quality Assurance | Risk Management | Regulatory Affairs & Compliance | Regulatory Submissions |Regulatory Intelligence| Pharmaceutical Manufacturing | Audits | Vendor Assurance Qualification | Cross Functional Authorized Person for APVMA and TGA Licence | Biochemistry | Team Leadership | Product Management | Product Safety | Operations| RACI Member, APIMAA Member and Treasurer (Active Pharmaceutical Ingredient Manufacturers’ Association of Australia)
Ms Leah Thompson
I have been working in the pharma industry for 19 years. I have a strong Quality Control, Quality Assurance and Regulatory Affairs background in product development, manufacture and registration. I have successfully navigated all regulatory audits including routine TGA and FDA audits. In my roles, I have successfully improved GMP compliance to A1 (highest compliance rating). I also hold an executive position on the board of the (Australian Pharmaceutical Ingredients Manufacturer’s Association of Australia (APIMAA) and have been involved in liaising with the TGA in the implementation of GMP regulations.