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Regulatory Affairs
We support companies in achieving compliance with national and international regulations, guiding them through the authorization and registration processes for medicines, medical devices, dietary supplements, and cosmetics. With proven expertise in Regulatory Affairs, Pharmacovigilance, Quality Management, and Health Technology Assessment (HTA), we provide targeted strategies and regulatory compliance to accelerate market access and ensure product safety and efficacy.
A team of experts analyzing data on computer screens.
Pharmacovigilance and Post-Marketing Surveillance
We provide structured Pharmacovigilance systems and continuous monitoring, ensuring timely risk management and full regulatory compliance to protect the safety of patients and healthcare professionals. With our proactive approach, we support pharmaceutical, medical device, dietary supplement, and cosmetic companies in meeting national and international pharmacovigilance requirements.
A quality assurance specialist inspecting a production line.
Quality Management System
We implement Quality Management Systems (QMS) to optimize business processes, enhance traceability, and ensure compliance with regulatory standards in the pharmaceutical, nutraceutical, cosmetic, medical device, and healthcare sectors. Our approach guarantees efficiency, reliability, and continuous improvement, helping companies achieve and maintain the highest standards of quality and regulatory compliance.
Researchers conducting experiments in a bright laboratory.
Research & Development
We support companies in the development of medicines, medical devices, dietary supplements, and cosmetics, providing scientific and operational consulting at every stage: from formulation to market launch. With our expertise in Research & Development (R&D), we ensure quality, regulatory compliance, and innovation, reducing development timelines and accelerating market access in regulated sectors.

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.

Health Technology Assessment (HTA)

Esperti in sala riunioni che analizzano dati clinici ed economici – 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.

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