- Our Services
Expertise and focus areas
Quarex consulting LLC assist clients in their projects to ensure compliance and training. Consultants provide technical expertise in quality and regulatory and conduct compliance gaps analysis, audits by certified auditors, support in writing files and implementation of processes. They are also able to provide regular training required in the EU.
We highly recommend to sub-contract audits to Quarex Consulting LLC in order to have a new independent eye on the QMS and Technical documentations and significantly improve the processes.
Our areas of expertise
Medical devices
Regulatory
Strategic Regulatory Planning: Determine classification & regulatory strategy on performance & safety, drafting documentation, selecting Notified Bodies, and Authorized Representatives, manage submissions roadmap.
Compliance Analysis: Evaluate product and labeling compliance, ensuring adherence to EU/UK/Switzerland regulations.
Technical Documentation Support: Assist in creating Technical Files compliant with MDR Regulation (EU) 2017/745, ISO 14971, IEC 62304, IEC 62366, UKCA requirements, Clinical Evaluation, MEDDEV 2.7.1, PMS, and PMCF.
CE & UK Marking Assistance: Guide through the process of CE and UK marking.
Technical Documentation Audits: Conduct audits to ensure compliance with medical device regulations.
Registration Support: Aid in the registration process across EU countries, UK, and Switzerland.
Global Product Registration: Provide support for GPR registration worldwide.
Reimbursement Strategy Development: Develop strategies for reimbursement in French and German markets.
Quality
Creating and deploying Quality Management System (QMS) documentation compliant with ISO 13485 and MDR Regulation (EU) 2017/745.
Conducting ISO 13485 internal/ blank audits to ensure compliance to standards and identify areas for improvement.
Monitoring, and analyzing processes, defects, and failures in production, employing Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) methodologies.
Collaboration with authorities to resolve major NC & accelerate certification process.
Our areas of expertise
Food
Regulatory
Regulatory Affairs Territory Strategy: Develop a comprehensive plan outlining regulatory approaches specific territories and optimizing market access.
Compliance Gap Analysis: Conduct in-depth assessments to identify gaps between current practices and regulatory requirements.
*Formulation Compliance Management: Provide expertise in navigating regulatory requirements related to herbal ingredients, additives, technical aids, contaminants, and other formulation components, ensuring adherence to applicable standards and regulations.
*Claim Strategy Development: Formulate strategic approaches for product claims in alignment with regulatory guidelines, maximizing the product's market potential while minimizing regulatory risks.
*Labeling Review and Optimization: Perform thorough reviews of product labeling to ensure accuracy, completeness, and compliance with regulatory requirements.
Quality
ISO 22000 Process Compliance Management: Ensure compliance to ISO 22000 standard by implementing robust processes and systems to guarantee food safety throughout the production chain.
Food Safety Audit and Certification Assistance: conducting food safety audits and attaining certifications, whether for internal manufacturing sites or Contract Manufacturing Organizations (CMOs), ensuring compliance with industry standards and regulatory requirements.
Regulatory Liaison and Non-Conformity Resolution: Assist in engaging with regulatory authorities to address non-conformities identified during audits, developing and implementing effective action plans to rectify issues.
Our areas of expertise
Medicines
Regulatory
Regulatory support in CMC writing
Support in registration in EU countries: Offer guidance and assistance throughout the registration process in European Union (EU) countries, streamlining regulatory submissions and navigating the complexities of local regulations for market access.
Quality
QMS Documentation Development and Implementation: Strategically create and deploy Quality Management System (QMS) documentation in accordance with European Union (EU) Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), ensuring regulatory compliance and operational efficiency.
GMP and GDP Audit Services: Provide comprehensive auditing services to assess compliance with GMP and GDP standards, identifying areas for improvement