プロフィール詳細

プロジェクトを作成

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Dr. Patricia D.に依頼

Brazil

PhD Pharmacist | Scientific & Regulatory Writer | Pharmaceutical R&D Expert

プロフィール概要

I am a Pharmacist with a PhD in Sciences Applied to Health Products (UFF) and a Master’s degree in Pharmaceutical Sciences (UFRJ), combining over 28 years of experience across academia and the pharmaceutical industry. My expertise lies in scientific and regulatory writing, pharmaceutical R&D, and quality and compliance systems. Throughout my career, I have held leadership roles as a professor and academic coordinator, teaching undergraduate and technical-level programs in Pharmacy, Nutrition, and related health sciences. In the industrial setting, I have led projects in formulation development, nanotechnology, drug delivery systems, analytical method validation, and regulatory affairs. I have authored and reviewed comprehensive regulatory dossiers for drug registration, post-approval variations, and compliance with Brazilian Health Regulatory Agency (ANVISA) standards. Currently, I serve as a Galenic Development Analyst at the National Institute for Quality Control in Health (INCQS/FIOCRUZ), and I collaborate on research initiatives focused on biopolymers and nanotechnology applied to health products. I am a proactive, results-driven professional with a strong passion for scientific innovation, medical and regulatory writing, and knowledge transfer. I am open to new freelance opportunities in medical writing, regulatory consulting, formulation science, and technical content development.

専門分野

• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ Drug Target Identification
• ☆ Medicinal Chemistry
• ☆ Drug Design
• ☆ Structure-Activity Relationship (SAR) Studies
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Solid Form Screening
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Pharmacogenomics
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Antibiotic Development
• ☆ Bioavailability
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Human Biology
• ☆ Clinical Laboratory Science
• ☆ Clinical Biochemistry
• ☆ Blood Banking & Transfusion Medicine
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Psychoactive Drugs
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

サービス

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

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, General Proofreading & Editing

Research Meta-Research, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

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

職務経験

Universidade Federal Fluminense

- 現在

Pharmaceutical Formulation Development Analyst

Fundação Oswaldo Cruz

6月 2025 - 現在

Coordenador/Professor

Centro Universitário de Valença - Unifaa

12月 2024 - 7月 2025

Professor Substituto

Universidade Federal Fluminense

9月 2022 - 9月 2024

Coordenador/Professor

Universidade Estácio de Sá

9月 2006 - 12月 2019

Gerente da Qualidade

Nortec S.A.

8月 2013 - 10月 2014

Analista de Desenvolvimento Galênico e Responsável Técnico

Laboratório Químico Farmacêutico do Exército

2月 2006 - 2月 2013

学歴

Doctorate

Universidade Federal Fluminense - UFF

2月 2020 - 8月 2024

Mestre

Universidade Federal do Rio de Janeiro - UFRJ

7月 2006 - 7月 2009

Farmacêutico Industrial

Universidade Federal do Rio de Janeiro - UFRJ

3月 1994 - 3月 1996

Farmacêutico

Universidade Federal do Rio de Janeiro - UFRJ

3月 1990 - 3月 1994

認定資格

• 認定資格の詳細は未入力です。