Tag : Ointments and therapeutics
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Global Regulatory Affairs Training Course Content
- Provide regulatory strategy in order to achieve best preparation and approval time for regulatory dossiers (Brazil, Costa Rica, Egypt, Guatemala, Indonesia, Iraq, Ivory coast, Jamaica, Kenya, Malaysia, Mexico, Myanmar, Nepal, Nigeria, Pakistan, Peru, Philippines, Russia, Sri Lanka, Sudan, Syria, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkmenistan, Turkey, Ukraine and Venezuela).
- Dossier submission as per eCTD/CTD/ACTD/NeeS submission compilations
- Preparation of dossiers as per ANDA
- Preparation of documents to import cosmetics
- Preparation and review of Product summary file (PSF) to WHO for the vaccines DTPwH-HIB, DTPwH, Tetanus Toxoid and Hepatitis-B vaccines as a part of prequalification to WHO.
- Preparation and review of PSF reassessment to WHO.
- Preparation of dossiers for Diagnostic kits
- Knowledge about GLP, GMP and GCP
- Dossier preparation for Australia as per TGA guidelines
- Dossiers preparation for Tables, Capsules, Liquids, Ointments and therapeutics
- Dossiers preparation as per Common technical document (CTD) and ACTD.
- Determine, evaluate and summarize data requirements for submissions and change controls to ensure regulatory needs.
Annual post approval changes notification to WHO.
Post approval changes notifying to other countries as per the guidelines.
Change control review and notifying to DCG(I) as a part of post approval changes if any.
Post approval changes submissions to DCGI as per CDSCO Guidelines.
Level I – Supplements (Major Quality Change)
Level II – Notifiable changes (Moderate Quality change)
Level III – Annual Notification (Minor Quality change)
- Prepare responses to Deficiencies & Queries from regulatory authorities.
Keep abreast of changes to relevant regulations, policies, guidelines (FDA & ICH) training to internal/external stakeholders
- Extensive experience in handling regulatory requirements through the product life cycle both in preapproval as well as post approval phases
- Coordination with auditors for the execution of the audit and provide necessary documents
- DCA/DCGI related works (documents submission for WHO – GMP certificate, Certificate of pharmaceutical product (COPP), import license, Free sale certificate, and for other country specific requirements.
- Review of country specific regulations and interpretation of guidelines to provide required data for submission
- Query response subsequent to submission of dossier
- Country specific Art work preparation and review
- Regulatory follow up with agents for faster registration