Regulatory Affairs
Pharmacovigilance and Post-Marketing Surveillance
Quality Management System
Research & Development
Auditing & Compliance: ensuring adherence to the highest regulatory standards. We support companies with internal and external audits, regulatory inspections, and compliance strategies aligned with GMP, GDP, GVP, and ISO standards, ensuring quality and continuous improvement.
Face inspections with confidence and maintain the highest regulatory standards. We provide comprehensive support for internal and external audits, ensuring compliance with international regulations such as GMP, GDP, GVP, and ISO.
Regulatory compliance and certified quality are essential for the sustainable growth of any company. Our expert team supports organizations in the management and implementation of audits, preparing them for regulatory inspections, compliance reviews, and audit strategies. We ensure alignment with major standards — GMP, GDP, GVP, and ISO — delivering tailored solutions focused on continuous improvement.
- Preparazione ad audit e ispezioni. Ti affianchiamo nella pianificazione e gestione di controlli e visite ispettive, garantendo conformità normativa e pieno allineamento agli standard GMP, GDP, GVP e ISO.
- Supporto alla certificazione. Guidiamo la tua azienda nell’iter di conformità e certificazione secondo gli standard GMP, GDP, GVP e ISO, garantendo qualità, affidabilità e pieno rispetto delle normative internazionali.
- Audit interni ed esterni. Analizziamo e ottimizziamo i processi aziendali per garantirne l’aderenza agli standard normativi e alle linee guida internazionali come GMP, GDP, GVP e ISO, supportando le aziende verso qualità e conformità continua.
- Miglioramento continuo. Elaboriamo strategie su misura per rendere i processi aziendali più efficaci, tracciabili e conformi agli standard internazionali, favorendo qualità, efficienza e sostenibilità nei settori farmaceutico, nutraceutico, cosmetico, dispositivi medici e sanitario.
- Compliance documentale. Supportiamo le aziende nella redazione, gestione e aggiornamento della documentazione di qualità, assicurando tracciabilità, conformità normativa e allineamento agli standard internazionali come GMP, GDP, GVP e ISO.
Health Technology Assessment (HTA)
Health Technology Assessment (HTA) is a multidimensional process that evaluates the clinical, economic, organizational, ethical, and social implications of health technologies.
The goal of Health Technology Assessment (HTA) is to support informed, evidence-based decision-making in healthcare, robust scientific evidence,ensuring that the introduction and use of medicines, medical devices, procedures, and organizational systems are effective, safe, and sustainable in the long term.
Through Health Technology Assessment (HTA), public and private healthcare institutions can:
Evaluate the safety and clinical effectiveness of innovations;
Analyze costs and cost-effectivenessoptimizing the use of available healthcare resources;
Identify organizational impacts on internal processes and healthcare staff;
Consider ethical and social aspectssuch as equity of access and quality of care;
Define strategic priorities for the adoption of health technologies.
S.A.R. Pharma supports hospitals, clinics, and healthcare institutions in carrying out HTA analyses customized and indipendent,providing
Clear, detailed reports based on robust scientific evidence;
Indicators for monitoring quality and impact;
Support for decision-makers in the evaluation process and communication with stakeholders.
Thanks to an integrated and multidisciplinary approach, Health Technology Assessment (HTA) makes it possible to combine technological innovation, economic sustainability, and improved quality of healthcare services, fostering informed and value-based decisions.