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Welcome to Oribase Health Sciences

Your trusted partner in regulatory affairs, pharmacovigilance, and Patient Support Program, dedicated to ensuring compliant product registration, robust patient safety oversight, and enhanced healthcare solutions.

 

About Us

At Oribase Health Sciences, we specialize in pharmaceutical services with a focus on pharmacovigilance, regulatory registration, and Patient Support Programs. Our mission is to partner with pharmaceutical companies to deliver high-quality support tailored to the unique needs of patients in Tunisia. Guided by our vision to expand our expertise and strategic reach, we strive to provide exceptional value for all stakeholders involved. Explore more about our journey and core values.

Our Core Values

Commitment to Patients

We prioritize patient welfare and strive to provide the highest standard of support.

Integrity and Ethics

Our operations are rooted in trust, transparency, and adherence to all ethical standards.

Continuous Improvement

We are dedicated to evolving our services and strategies to better meet the needs of our clients and patients.

Our Services

Regulatory Activities

  • Regulatory strategy & local implementation
  • Marketing Authorization (NDA, renewals, variations)
  • Labeling & compliance review (SmPC, artwork, leaflet)
  • Authority liaison & dossier follow-up (ANMPS)
  • Regulatory intelligence & reporting
  • Post-approval market access, pricing & tendering support

Patient Support Program

Customized support strategies tailored to individual patient needs, including nurse support programs and disease management.


  • Patient Support call center;
  • Nurse support program;
  • Disease management programs;
  • Copayment program;
  • Market research ;

Pharmacovigilance Activities

  •       ✔ QPPV/LPPV Outsourcing Responsibilities   
    ✔ PSUR and RMP Writing
    ✔ Literature Screening
    ✔ ICSR Drafting
    ✔ PSMF/PSSF Creation
    ✔ Pharmacovigilance Audits (qualified auditors accross MENA and Europe)
    ✔ PV Department Establishment
    ✔ PV Audits and Pre-Audit Preparation
    ✔ CAPA Audit Implementation

Regulatory Compliance Consulting

Assisting Pharma companies in navigating complex regulatory landscapes to ensure compliance and safety.

Market Research and Analysis

Thorough market insights and data-driven strategies to enhance service efficacy and patient engagement.

Training and Development Programs

Specialized training for healthcare professionals on pharmacovigilance standards and patient support frameworks.

Get In Touch With Us

At Oribase Health Sciences, we're dedicated to providing tailored solutions for your pharmaceutical needs. Reach out to discuss how we can support your projects and enhance patient care. Our team is here to assist you every step of the way.

Address

BiotechPole Sidi Thabet, Ariana 2020, Tunisia