Pharmaceutical
& regulatory affairs
Pharmaceutical
& regulatory affairs
At Axelys Santé, we understand the importance of pharmaceutical and regulatory affairs in the development, registration and operation of health products – medicines, medical devices, in-vitro diagnostic medical devices -, cosmetic products and food supplements. . Our team of experts guide you in all of your strategies through the technical and regulatory complexities to ensure compliance and the success of your projects.
Regulatory procedures.
Pharmaceutical assistance.
Compliance and development of Management System Quality.
Regulatory procedures
We support our clients in their regulatory submussions for clinical research or requests and variations for Marketing Authorization (AMM), CE marking, etc. Our team of experts carries out continuous regulatory monitoring and notifies you in real time of any changes to standards and laws regarding your products.
Regulatory procedures
We support our clients in their regulatory filings for clinical research or requests and variations for Marketing Authorization (AMM), CE marking, etc. Our team of experts carries out continuous regulatory monitoring and notifies you in real time of any changes to standards and laws relating to your products.
Pharmaceutical assistance to operating laboratories
Our pharmaceutical support services include the provision of assistant pharmacists and interim responsible pharmacists (PRI), who support you with batch tracking, recall management and regulatory compliance of packaging. We also offer assistance with managing and updating quality systems, preparing for inspections, and effectively managing your subcontractors.
Pharmaceutical assistance to operating laboratories
Our pharmaceutical support services include the provision of assistant pharmacists and interim responsible pharmacists (PRI), who support you with batch tracking, recall management and regulatory compliance of packaging. We also offer assistance with managing and updating quality systems, preparing for inspections, and effectively managing your subcontractors.
External communication
Our team ensures that all of your communication documents meet regulatory standards. We control advertising and manage advertising visa application files, intended for health professionals and the general public, guaranteeing that the promotional material used by your field force complies with the requirements of the ANSM.
External communication
Our team ensures that all of your communication documents meet regulatory standards. We control advertising and manage advertising visa application files, intended for health professionals and the general public, guaranteeing that the promotional material used by your field force complies with the requirements of the ANSM.
Compliance and legal procedures
Our expertise also extends to legal and compliance procedures. We manage everything relating to the Compliance with Anti-gift law & French Sunshine Act and transparency. This consists in drafting agreements, filings on the IDAHE2/EPS platforms, and monitoring declarations of links of interest. In addition, our expertise in personal data protection (GDPR) ensures that all procedures are in perfect compliance with the requirements of the CNIL.
Compliance and legal procedures
Our expertise also extends to legal and compliance procedures. We manage everything relating to the Compliance with Anti-gift law & French Sunshine Act and transparency. This consists in drafting agreements, filings on the IDAHE2/EPS platforms, and monitoring declarations of links of interest. In addition, our expertise in personal data protection (GDPR) ensures that all procedures are in perfect compliance with the requirements of the CNIL.
Quality Management System
Our expertise in quality management systems (QMS) enables us to validate your operational documents, manage your quality systems and facilitate your internal or subcontractor audits. Our proactive approach to risk management and continuous improvement ensures that your processes and systems remain at the cutting edge of efficiency and compliance.
Quality Management System
Our expertise in quality management systems (QMS) enables us to validate your operational documents, manage your quality systems and facilitate your internal or subcontractor audits. Our proactive approach to risk management and continuous improvement ensures that your processes and systems remain at the cutting edge of efficiency and compliance.
By choosing Axelys Santé for your pharmaceutical and regulatory affairs needs, you are choosing a trusted partner who understands the challenges inherent in these areas. Complex regulatory aspects will thus be managed with greater ease and efficiency.
For more information on how we can assist you in your pharmaceutical and regulatory projects and ensure the compliance of your products, do not hesitate to consult our services and contact our team of experts directly.
