Skip to content



We can assist you in the performance of procedures related to the detection, evaluation, comprehension and prevention of Adverse Drug events. We are experts in: Intensive Pharmacovigilance, compliance with regulatory demands, Master File documents, aligning of global reports with local requirements.


We oversee the safety of your Medical Devices, offering customised support aligned with national and international applicable legislation and product cathegorisation.


Our experts provide assistance to comply with Cosmetics safety requirements, strictly adhering to both local and global regulations.

Local qualified person (LSO/LCPPV/LQPPV)

We count with a network of healthcare professionals eligible for nomination as responsible persons for pharmacovigilance, cosmetovigilance and/or technovigilance before regulatory authorities.
- Extensively trained
- Experienced in risk-benefit assessment

Safety Reports Management

We offer assistance for the management of Adverse Event Reports. We can receive, track, process, evaluate and/or submit them to Health Authorities according to standardized procedures.

Local and International Scientific Literature Monitoring

We conduct surveillance on national and international scientific literature. This enables us to identify Adverse Events and gather relevant safety information for the assessment of profiles and risk-benefit ratios of your products.

Regulatory Intelligence

We monitor the websites of regulatory authorities to promptly identify any updates in relevant legislation and health alerts.

Clinical Trials

We work closely with our clients in the entire process of pre-marketing studies, from developing protocols to execution, with a constant emphasis on safeguarding the well-being of participating volunteers.

Quality assurance

By fostering a culture of continuous improvement, employees training, adaptation to changes in the regulatory landscape, and strict document control, we ensure the traceability and quality applied to processes, while continuously monitoring them through indicators, internal audits based on international guidelines and proper risk management. Our team of experts is committed to rigorous compliance with local regulations, as well.

Diagnostic Audits

A thorough solution to guarantee your company's adherence to the utmost safety and regulatory guidelines. Our auditors, with extensive experience and certifications, conduct a meticulous diagnosis to identify risks within your safety unit management; uncovers improvement opportunities and suggest optimization actions for your processes. Additionally, we can support you on the preparation/response of Corrective and Preventive Action Plans (CAPAs).

Periodic Safety Update Reports

We prepare schedules for the timely submission to Health Authorities in accordance with prevailing local legislation. We meticulously write documents tailored to the requirements of each Agency, collating information from national and international scientific literature, signals, safety alerts, and risk-benefit assessments. We also translate and adapt global PSURs/PBRERs to meet local regulatory requirements.

Risk Management Plans

We develop plans to mitigate risks. In addition, we can assist you in translating and adapting global documents to meet the nuanced requirements of specific local regulations.

Medical Information

Our team of specially trained physicians will provide current and scientifically validated evidence to address medical information inquiries. We prepare Dear Doctor Letters and contribute to the revision and update of product leaflets.


We carry out strategies, create, implement, and manage training programs, ensuring that the staff keep current in their activities and knowledge.

Units Start-Ups

We specialise in the establishment and configuration of safety units and their quality systems. This includes the preparation of Standard Operating Procedures (SOPs) outlining activities development, local forms and templates and providing comprehensive training. Moreover, we develop annual training plans, strategies for bibliographic monitoring and local submission schedules, aligned with the international ones, when allowed.

Inspection Readiness Plan

We replicate the scenario of an inspection conducted by local/regional authorities to enhance the efficiency of safety unit operations in compliance with applicable requirements.

Patient Support Programs

We manage and execute programs, providing guidance and advice to attending physicians. By engaging with healthcare professionals and patients, we also gather safety-related information.