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)
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
EU medical device regulatory consulting
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.
MDR/IVDR transition and submission readiness assessments
Gap analysis, dossier readiness review, remediation planning and timeline alignment relative to notified body capacity and certification deadlines.
Regulatory evidence synthesis and literature support
Structured literature screening, evidence grading and preparation of regulatory-ready study summaries to support clinical evaluations, PMCF and safety reports.
Training design and delivery for regulatory and clinical teams
Custom training and workshops on clinical evaluation, pharmacovigilance, regulatory documentation and organizational training needs analysis with curricula and evaluation strategies.
Operational risk management and security consulting
Multi-discipline operational risk assessments, vulnerability mapping, policy and procedure development, and exercise/training development for enterprise resilience.
Specialist team augmentation and technical staffing
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.
EU medical device regulatory consulting
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.
MDR/IVDR transition and submission readiness assessments
Gap analysis, dossier readiness review, remediation planning and timeline alignment relative to notified body capacity and certification deadlines.
Regulatory evidence synthesis and literature support
Structured literature screening, evidence grading and preparation of regulatory-ready study summaries to support clinical evaluations, PMCF and safety reports.
Training design and delivery for regulatory and clinical teams
Custom training and workshops on clinical evaluation, pharmacovigilance, regulatory documentation and organizational training needs analysis with curricula and evaluation strategies.
Operational risk management and security consulting
Multi-discipline operational risk assessments, vulnerability mapping, policy and procedure development, and exercise/training development for enterprise resilience.
Specialist team augmentation and technical staffing
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