As a Laboratoire Exploitant in France, we are responsible for the regulatory compliance of the medicines we distribute. This status underlines our commitment to meeting the highest standards of safety, efficacy, and regulatory oversight in the pharmaceutical industry.
Strategic Regulatory Planning
A well-defined regulatory strategy is essential to pharmaceutical success. We collaborate closely with partners to develop regulatory plans that align with business objectives and stringent Health authority requirements.
Regulatory Submissions and Dossier Preparation
We provide expert support in the submission of marketing authorization (MA) dossiers, ensuring compliance with the requirements of regulatory agencies such as the European Medicines Agency (EMA) and national authorities like the French National Agency for Medicines and Health Products Safety (ANSM). Our role is to assist pharmaceutical companies in compiling and presenting scientific data/clinical trial results, facilitating a smoother and more efficient review process.
Liaison with Regulatory Authorities
Maintaining clear and effective communication with regulatory bodies is essential. Our team acts as an intermediary, managing correspondence, addressing queries, and providing necessary clarifications to expedite approvals.
Regulatory Intelligence & Compliance Monitoring
Intsel Chimos provides constant intelligence services, monitoring legislative changes to ensure partners remain informed and compliant.
At Intsel Chimos, we have developed a robust distribution network that guarantees the timely and secure delivery of pharmaceutical products to hospitals, wholesalers, community pharmacies, and healthcare providers, all while maintaining the highest standards of product integrity and regulatory compliance.
Adherence to regulatory standards is a cornerstone of our logistics and supply chain operations. We comply with Good Distribution Practices (GDP) to ensure that all products are stored, handled, and transported according to stringent quality requirements. Our quality assurance team conducts regular audits to maintain compliance and uphold the integrity of our supply chain.
Temperature controlled Storage and Transportation
Many pharmaceutical products require specific temperature conditions during storage and transportation. Our cold chain logistics solutions are equipped with advanced temperature control systems and monitoring devices to ensure that these products remain within the required temperature ranges throughout the supply chain. This capability is crucial for maintaining the stability and effectiveness of temperature-sensitive medications (+2/+8°C, +15/+25°C, frozen products).
Order to Cash Process
Our selling team manages all orders received by Healthcare professionals on a daily basis. All orders are processed and delivered within 24 hours. We also handle the invoicing and cash collection process by supplying invoices on the official Chorus platform.
Advanced Technology Integration
To enhance visibility and transparency across the supply chain, we have integrated cutting-edge technologies such as real-time tracking systems and digital inventory management platforms. These tools enable us to monitor shipments in real-time, anticipate potential disruptions, and make data-driven decisions to maintain the continuity of supply.
At Intsel Chimos, our Pharmacovigilance & Quality Assurance services are meticulously designed to monitor, assess, and enhance the safety profiles of medications throughout their lifecycle.
Pharmacovigilance: Safeguarding Patient Health
Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Our dedicated team employs robust systems to collect and analyze data on adverse drug reactions (ADRs).
Quality Assurance (QA): Ensuring Product consistency and safety
Quality Management Systems (QMS): Our comprehensive QMS integrates all aspects of quality assurance, facilitating continuous improvement and compliance with international standards based on Good Distribution Practices (GDP) compliance, Good Manufacturing Practices (GMP) Compliance, and also fully compliant with the French Public Health Code (CSP)
Our Quality Assurance Service is subject to continuous improvement through regular internal and external audits as well as ongoing training programs for our staff.
At Intsel Chimos, we offer customized services tailored to the unique needs of the French pharmaceutical market.
Strategic Market Analysis
Understanding the market landscape is the foundation of any successful promotional campaign. Our team conducts in-depth analyses to identify target audiences, assess competitive environments, and uncover market opportunities. This data-driven approach enables us to craft strategies that resonate with healthcare professionals and patients alike.
Sales Force Excellence
Our dedicated sales team is trained to effectively communicate the value propositions of our partners products to healthcare professionals. Through personalized interactions and evidence-based discussions, we facilitate informed decision-making and product adoption. We make sure to maintain at all stages of the promotion plan :
Regulatory Compliance in Promotion
We ensure that all promotional materials and activities comply with French regulations and ethical standards, maintaining the integrity of our clients and safeguarding public health.