プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Robin A.に依頼

Sweden

Elite Chemistry RegTech | ICH M7/Nitrosamines/Bayesian Modeling

プロフィール概要

I deliver audit-grade, regulator-defensible, visually flawless governance and scientific documents that survive FDA, EMA, and courtroom scrutiny — Lancet/Big-4 aesthetic, zero legal exposure. Core domains: • ICH M7 / nitrosamine (NDSRI) risk assessment & control strategies • Genotoxicity (Derek/Sarah + dual QSAR + expert WoE) • Bayesian ensemble risk modeling & stress-testing • CMC / IND Module 3.2.S drafting (impurities, justifications) • BIOSECURE supply-chain resilience & Scope 3 / PFAS integration • PBPK pediatric extrapolation & RWE portfolio strategy 100+ high-impact deliveries: breakthrough therapy designations, conditional MAs, nitrosamine white papers, ESG integration guides. Every document includes Mermaid DAGs, SHAP explainability, shadowed TikZ visuals, gold-accented headers — delivered in 48–96 h. Explicitly non-operational / advisory-only (no legal opinions). Fixed-price briefs $2,500–$18,000 | Fractional retainers: 20–40 hours/month at $160/hour. Achieve Class III MDR compliance for 75%+ less than traditional consultancies ($8,900 fixed-fee vs. $38k–$95k average) Samples below — have a look, and then let me do my thing!

専門分野

• ★ Regulatory Writing
• ★ NDA/BLA Applications
• ★ Investigational New Drug (IND) Application Writing
• ☆ Publishing
• ☆ Multilingualism
• ☆ Drug Development
• ☆ Drug Stability Testing
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ CMC Documentation
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Medical Copywriting
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Formulation
• ☆ Pharmaceutical Formulation
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis

Product Development Formulation, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Principal Consultant | Computational Chemistry & RegTech

Artless Passion

1月 2025 - 現在

Principal Consultant | Chemistry RegTech & Pharmaceutical Governance

Artless Passion

7月 2021 - 現在

Computational & Theoretical Chemistry Specialist

Independent Researcher

12月 2018 - 1月 2024

学歴

PhD in Computational Chemistry

Independent / Industry-sponsored research

1月 2018 - 6月 2024

Partial Law Degree

Uppsala University

1月 2020 - 6月 2021

認定資格

• 認定資格の詳細は未入力です。

出版物

PREPRINT

Nitrosamine Risk Governance Framework — EMA/FDA/ICH M7(R2) Decision Memo & Evidence Log (Audit-Ready, Non-Operational Reference Example) – .

Alighieri, Robin(2025). Scope 3 Emissions and PFAS Risk in Pharma Supply Chains: An Audit-Ready Integration Guide (Executive Brief) . Zenodo

Alighieri, Robin(2025). Eliciting a Definitive Technical Monograph from a Large Language Model: A Case Study in Advanced Prompt Engineering . Zenodo

JOURNAL ARTICLE

Lindgren, R. A. Kinetics and Mechanism of the Acid-Catalyzed Hydrolysis of Acetylsalicylic Acid in Aqueous Solution. Private Researcher Manuscript, 2025.