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Kolabtreeを選ぶ理由

開始はすばやく簡単です。初期費用はかかりません。

サービス依頼と専門家への見積依頼は無料です。

Kolabtree の作業範囲に同意する前に、専門家と要件を詳しく相談できます。

専門家と直接連携し、必要な成果を正しく得られます。

専門家を採用したらプロジェクトに資金を入れ、作業完了後に成果物を承認できます。

Lini S. に連絡

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Kolabtreeを選ぶ理由

この専門家をプロジェクトに採用したいですか？見積もりを依頼無料で。

プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Lini S.に依頼

India

Regulatory Affairs Expert with 20 Years Experience (Regulatory and Scientific Writing Services)

プロフィール概要

Specialities
- Well-versed in EU Registration procedures (DC/MR, CP and nationals).
- CMC Dossier Development & writing
- Regulatory Strategy - Global strategy for Generic Drugs, New Drugs, Generic fixed dose
combinations & biosimilars/biologics for global markets EU, US, TGA, Swiss and other ROW
- Regulatory Dossier Due Diligence
- Implementation and maintenance of electronic dossier tools
- Scientific advice meetings, Briefing packages and controlled correspondence with the regulators
- Dossier development for innovative drugs
- EU Lifecycle maintenance – All types of variations, renewal, update of product information based on safety updates
- CTD/NeeS/eCTD Compilation of dossiers, Review and publishing in electronic format
- Documentation and Quality Management Systems
- Vendor qualification/assessment, contract validation &business proposal review
- Deliverable/Scope of work setting in the pre-sale/Business Development phase and inputs towards business intelligence case studies
- Training & Development to business & project management team globally
- Project Management

専門分野

サービス

Writing
Research
Consulting
Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study

Consulting Scientific and Technical Consulting

Product Development Formulation

職務経験

Senior Regulatory Expert

Silmed Scientific

3月 2019 - 現在

学歴

MSc Pharmaceutical Chemistry

Mahatma Gandhi University

6月 2002 - 7月 2004

認定資格

認定資格の詳細は未入力です。