Arete-Zoe
Arete-Zoe is a consultancy specializing in systems approach to solution development and implementation within the medical device, pharmaceutical, and healthcare sectors. They focus on regulatory compliance, clinical documentation, research support, training, operational risk management, cybersecurity, biological threat preparedness, and organizational resilience. Their mission is to help clients navigate complex regulatory environments, mitigate risks, and enhance organizational resilience, especially in the context of EU MDR and IVDR regulations, certification processes, and global pharmaceutical security. They aim to optimize organizational effectiveness, ensure compliance, and support innovation in high-stakes environments.
Industries
Nr. of Employees
small (1-50)
Arete-Zoe
1334 E Chandler Blvd, Box 5A-19, Phoenix, AZ 85048, USA
Products
Global Pharma Primer
Published primer providing background information relevant to the pharmaceutical sector.
Pharmaceutical Supply Chain Security & Integrity
Publication focused on supply chain risks and integrity in the pharmaceutical sector.
Survival Guide to Stem Cells Research and Therapies
Guidance and background material on stem cell research and therapies.
Compiled biodefense reference materials
Compiled literature and slide materials on biological risk, attribution, biodefense policy and related technical topics used as reference and training material.
Global Pharma Primer
Published primer providing background information relevant to the pharmaceutical sector.
Pharmaceutical Supply Chain Security & Integrity
Publication focused on supply chain risks and integrity in the pharmaceutical sector.
Survival Guide to Stem Cells Research and Therapies
Guidance and background material on stem cell research and therapies.
Compiled biodefense reference materials
Compiled literature and slide materials on biological risk, attribution, biodefense policy and related technical topics used as reference and training material.
Services
Support preparing technical documentation and submissions for conformity assessment under EU MDR/IVDR, including dossier assembly, submission packaging and interaction with notified bodies and authorities.
Gap analysis, dossier readiness review, remediation planning and timeline alignment relative to notified body capacity and certification deadlines.
Structured literature screening, evidence grading and preparation of regulatory-ready study summaries to support clinical evaluations, PMCF and safety reports.
Custom training and workshops on clinical evaluation, pharmacovigilance, regulatory documentation and organizational training needs analysis with curricula and evaluation strategies.
Multi-discipline operational risk assessments, vulnerability mapping, policy and procedure development, and exercise/training development for enterprise resilience.
Provision or coordination of clinical experts, regulatory specialists and technical writers to complete sections of technical documentation or to augment in-house teams for submission timelines.
Support preparing technical documentation and submissions for conformity assessment under EU MDR/IVDR, including dossier assembly, submission packaging and interaction with notified bodies and authorities.
Gap analysis, dossier readiness review, remediation planning and timeline alignment relative to notified body capacity and certification deadlines.
Structured literature screening, evidence grading and preparation of regulatory-ready study summaries to support clinical evaluations, PMCF and safety reports.
Custom training and workshops on clinical evaluation, pharmacovigilance, regulatory documentation and organizational training needs analysis with curricula and evaluation strategies.
Multi-discipline operational risk assessments, vulnerability mapping, policy and procedure development, and exercise/training development for enterprise resilience.
Provision or coordination of clinical experts, regulatory specialists and technical writers to complete sections of technical documentation or to augment in-house teams for submission timelines.
Expertise Areas
- EU MDR/IVDR regulatory submissions and compliance
- Clinical evaluation and PMCF for medical devices
- Post-market surveillance and pharmacovigilance
- Systematic literature review and regulatory evidence synthesis
Key Technologies
- Next-generation sequencing (NGS)
- High-performance computing (HPC) for genomics
- Big data analytics for pathogen and genomic data
- Secure cloud and data center architectures
News & Updates
An article discussing the challenges and solutions related to the transition to EU MDR, certification backlog, and risk mitigation strategies.
An article emphasizing the importance of enlightened leadership in organizational effectiveness and risk management.
Systems Approach to Solution Development & Implementation
Overview of the company's approach to developing and implementing solutions in the medical and pharmaceutical sectors.
The Dark Side of Pharma Globalization
Discussion on vulnerabilities in the pharmaceutical supply chain and dependency on foreign production, highlighting risks of supply disruptions and data security.
Crash Course on the EU Medical Device Regulation - Part I & II
Educational content on the history, obligations, and implementation of EU MDR and IVDR regulations, including the impact of certification delays and backlog.
What does it take to place your Medical Devices on the European market?
An overview of the European medical technology sector, market dynamics, and regulatory environment, including the impact of MDR implementation and certification challenges.
An article discussing the challenges and solutions related to the transition to EU MDR, certification backlog, and risk mitigation strategies.
An article emphasizing the importance of enlightened leadership in organizational effectiveness and risk management.
Systems Approach to Solution Development & Implementation
Overview of the company's approach to developing and implementing solutions in the medical and pharmaceutical sectors.
The Dark Side of Pharma Globalization
Discussion on vulnerabilities in the pharmaceutical supply chain and dependency on foreign production, highlighting risks of supply disruptions and data security.
Crash Course on the EU Medical Device Regulation - Part I & II
Educational content on the history, obligations, and implementation of EU MDR and IVDR regulations, including the impact of certification delays and backlog.
What does it take to place your Medical Devices on the European market?
An overview of the European medical technology sector, market dynamics, and regulatory environment, including the impact of MDR implementation and certification challenges.