Scientific & Strategic Consulting

Expertise científico para decisiones que importan.

Scientific expertise for decisions that matter.

Consultoría especializada para compañías farmacéuticas, biotecnológicas, CROs e instituciones de salud, integrando farmacovigilancia, investigación clínica, medical affairs y estrategia regulatoria.

Specialized consulting for pharmaceutical and biotechnology companies, CROs and healthcare organizations, integrating pharmacovigilance, clinical research, medical affairs and regulatory strategy.

ServiciosServices

Soporte experto a lo largo del ciclo de vida del producto

Expert support across the product lifecycle

Servicios por proyecto, asesoría senior y soporte recurrente, adaptados a la necesidad de cada organización.

Project-based services, senior advisory and recurring support tailored to each organization.

PHARMACOVIGILANCE & DRUG SAFETY

Farmacovigilancia y gestión de seguridad

Pharmacovigilance & safety management

  • ICSR management and case review
  • PSUR / PBRER / DSUR
  • Risk Management Plans
  • Signal management & benefit–risk
  • SOPs, KPIs, training & compliance
  • e-Reporting, MedDRA and inspection readiness
MEDICAL AFFAIRS

Soporte médico-científico

Medical & scientific support

  • Medical writing and scientific review
  • Training and educational materials
  • Medical information support
  • Scientific communication strategy
  • Cross-functional medical support
CLINICAL RESEARCH

Investigación clínica

Clinical research

  • Protocol and study documentation support
  • Medical monitoring activities
  • Investigator and site support
  • GCP / ICH compliance
  • Clinical and technical report preparation
REGULATORY STRATEGY

Estrategia regulatoria

Regulatory strategy

  • ANMAT and LATAM regulatory support
  • Safety documentation for submissions
  • Regulatory responses and assessments
  • Inspection and audit preparation
  • Interfaces with Quality, Medical and Regulatory teams
EnfoqueApproach

Rigor científico, criterio regulatorio y ejecución práctica

Scientific rigor, regulatory judgment and practical execution

FADS Consulting transforma requerimientos complejos en soluciones claras, documentadas y aplicables, con foco en calidad, trazabilidad y sostenibilidad.

FADS Consulting translates complex requirements into clear, documented and actionable solutions, with a focus on quality, traceability and sustainability.

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Soluciones a medidaTailored solutions
Alcances adaptados a la realidad de cada organización.Scopes adapted to each organization’s reality.
✓
Visión médico-científicaMedical-scientific perspective
Interacción con equipos médicos, regulatorios, calidad y seguridad.Effective interaction with medical, regulatory, quality and safety teams.
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Compliance
Procesos trazables y preparados para auditorías e inspecciones.Traceable processes designed for audit and inspection readiness.
Dra. Florencia Amato De Simone
Founder & Senior Consultant

Dra. Florencia Amato De Simone

Médica especialista en Farmacología Clínica, con trayectoria en industria farmacéutica, farmacovigilancia, investigación clínica y autoridad sanitaria. Su experiencia combina visión médica, conocimiento regulatorio y gestión operativa de sistemas de seguridad.

Physician specialized in Clinical Pharmacology, with experience across the pharmaceutical industry, pharmacovigilance, clinical research and health authority environments. Her background combines medical expertise, regulatory knowledge and operational safety-system management.

Clinical PharmacologyPharmacovigilanceClinical ResearchMedical AffairsANMAT / LATAM
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ModalidadesEngagement models

Una modalidad de trabajo para cada necesidad

Flexible engagement models

Por proyecto

Project-based

Objetivos, alcance y entregables definidos.

Defined objectives, scope and deliverables.

Soporte recurrente

Recurring support

Acompañamiento mensual o periódico.

Monthly or periodic expert support.

Asesoría senior

Senior advisory

Consultas estratégicas y revisión independiente.

Strategic consultations and independent review.

Capacitación

Training

Programas in-company adaptados al equipo.

In-company programs tailored to your team.

ContactoContact

Conversemos sobre su próximo proyecto

Let’s discuss your next project

Para consultas sobre farmacovigilancia, medical affairs, investigación clínica o estrategia regulatoria.

For pharmacovigilance, medical affairs, clinical research or regulatory strategy inquiries.

contacto@fads-consulting.com