Contact Us
Av. Congreso 2157 6to 4, C1428. Buenos Aires, Argentina
Calle del Príncipe 12, Planta 4, A5, 28012. Madrid, Spain
Calle 37B Sur # 27B-135 Ap. 1303. Envigado, Medellín, Colombia
PVH LATAM
Services
Our services
OUR MAP
We have operations in almost 100 countries
Quality policy
- – We are a company with a focus on patient safety.
- – We provide continuous support, as we consider that working for patient safety is an ongoing task.
- – We have a sustainable Quality Management System at all levels of the organisation, promoting continuous improvement with the aim of achieving excellence in our services and the full satisfaction of our clients and employees.
- – We understand that Quality is our responsibility and we are committed to:
- – Providing high quality services
- – Strictly complying with regulatory requirements
- – Maintaining confidentiality and a strict personal data protection policy
- – Being aligned to current best practices
- – Running a Quality Management System, continually improving it alongside with the enhancement of our systems and processes
- – Empowering our employees through planned training programmes
- – Every day, striving to meet the expectations of our clients, patients and our own by building mutual trust.
Services
Our services
Pharmacovigilance
We provide assistance to adequately perform activities related to the detection, evaluation, understanding and prevention of Adverse Drug Events.
Technovigilance
We do Technovigilance (the monitoring of the safety of Medical Devices) providing personalised support based on the needs of our clients…
Cosmetovigilance
We develop Cosmetic Safety activities, known as Cosmetovigilance, adjusting the service to the needs of our clients in adherence to local and global legislation…
Local Qualified Person
We provide health professionals who can be nominated as responsible persons for pharmaco, cosmetic and/or technovigilance…
Safety Reports Management
We have structured and strict procedures for the reception of Adverse Event Reports, their processing, assessment and submition to the Health Authority.
Monitoring of Local and International Scientific Literature
We monitor biomedical reference journals and databases for the identification…
Regulatory Intelligence
We regularly monitor the websites of regulatory authorities in order to identify changes in applicable legislation as well as health alerts as soon as possible.
Clinical Trials
We collaborate with our clients in the development of pre-marketing studies from protocol confection to implementation…
Quality Assurance
Through a culture of continuous improvement, training of our employees, adaptation to changes in the regulatory environment and strict document…
Diagnostic audits
Our Pharmacovigilance Diagnostic Audit service offers a comprehensive solution to ensure that your company meets the highest standards of safety…
Periodic Safety Updates Reports
We provide the service of planning and preparation of schedules for the submission of periodic safety reports…
Risk Management Plans
We prepare Risk Management Plans for products or authorities requiring them. We translate and adapt global documents according to local requirements.
Medical Information
Our team of physicians is trained to respond to medical information queries, providing up-to-date, scientifically backed evidence.
Trainings
We plan, design, develop and coordinate training programmes for the industry to keep all employees up-to-date in their activities…
Units start-ups
Design and set-up of the quality system to manage products safety following customers’ requirements and in accordance with applicable legislation.
Inspection readines plan
We simulate the context of an inspection by local/regional authorities in order to optimise the operation of the unit in line with local…
Patient Program
We coordinate and implement patient support programmes, including guidance and advice to treating physicians. Through contacts with…