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Regulatory Confidence.
from Strategy to Market.

Integrated Regulatory Affairs, Pharmacovigilance,
Quality Assurance and Market Access for Pharmaceutical, Biotechnology and Medical Device Companies.

Let’s discuss
  • 20 Years in
    business
  • 200+ Years combined
    experience
  • 80+ Life sciences
    companies
  • 10+ Years with key
    international partners

Regulatory Excellence.

Unwavering Commitment.

For two decades, StrugoPharm has supported pharmaceutical, biotechnology and medical device companies with expert regulatory consulting and services. Our multidisciplinary team brings more than 200 years of combined experience across Israeli, EMA and FDA regulatory frameworks.

We provide regulatory services in Israel and the Palestinian Authority and, in collaboration with our international partners, help companies expand into the European Union, the United States and emerging markets.

Trusted by over 80 companies, we build relationships that last for years across products, submissions, authority interactions and evolving requirements. This continuity reflects our commitment to being a reliable, accountable long-term partner.

We turn complex requirements into clear decisions and take responsibility for execution. As your gateway to the Israeli market and local regulatory representative, we help you advance efficiently, remain compliant and bring products to patients without avoidable delays or costs.

Our Partners.

  • Regenold
  • Cencora
  • PrimeVigilance
  • Asphalion

Clients We Support

  • Multinational Pharma
  • Innovative Biopharma
  • Medical Devices
  • Biologics
  • Generic Manufacturers
  • Biotech
  • Digital Health
  • Global PV Providers
  • CROs

Multinational Pharma Biologics

Digital Health Medical Devices

Generic Manufacturers CROs

Biotech Global PV Providers

Innovative Biopharma

What Sets Us Apart We find regulatory possibilities others may miss

We look beyond the wording of regulations to understand their intent, how authorities apply them and where viable pathways may exist. By connecting regulatory, safety, quality and commercial considerations, we anticipate challenges and develop scientifically sound, defensible solutions even in complex or unfamiliar situations.

What clients value about StrugoPharm

  • Senior experts who remain directly involved
  • Strategic insight combined with hands-on execution
  • Inspection ready systems, secure data handling,
    and long-term commitment
  • Responsive, flexible support that adapts
    to changing needs
  • In-depth knowledge of Israeli regulatory affairs, pharmacovigilance
    and the regulatory frameworks of reliance countries
  • Continuously refined methods that support precise
    execution and practical knowledge sharing
  • Connecting local requirements with global development
    and commercialization plans

Proven in Practice

  • Compliance at
    Scale

    Maintains ongoing regulatory compliance for portfolios covering more than 200 products.

  • Accelerated Market Entry

    Secured biosimilar marketing authorization within seven months, enabling first to market entry.

  • Complex Portfolio Transfers

    Managed 10 marketing authorization transfer programs covering more than 200 products.

  • Proactive Risk Management

    Develops and manages multiple Risk Management Plans and associated risk minimization measures each year.

  • Extensive Safety Oversight

    Manages pharmacovigilance systems and provides QPPV services for more than 300 products.

Your Team, Strengthened Our Engagement Models

Our experts integrate seamlessly with your people, processes
and digital systems providing direct access, responsive support and clear accountability, without the need to coordinate multiple providers.

  • Project
    Support

    Focused expertise for submissions, gap assessments, authority responses and other defined needs.

  • Outsourced
    Function

    A fully or partially outsourced regulatory, quality or pharmacovigilance function that scales with your organization.

  • Local
    Representation

    Ongoing Israeli market support through Appointed Pharmacist, MAH, QPPV, QP, RP and other local representative services.

our offerings Integrated Expertise Across the Product Lifecycle.

From pharmaceuticals and advanced therapies to medical devices and digital health, StrugoPharm brings together the regulatory, safety, quality and market access expertise required to move products forward and support them throughout their lifecycle. We align local execution with your global strategy and standards

Medicinal Products

  • Pharmaceuticals
  • Biologics
  • Biosimilars
  • ATMPs
  • Cell & Gene Therapies
  • Generics
  • OTC Products
  • Combination Products

Medical Technologies

  • Medical Devices
  • IVDs
  • Medical Software

Digital Health

  • Digital Health Products

Regulatory Affairs

Clear Pathways. Confident Progress.

We define the regulatory pathway, manage submissions and authority interactions,
and maintain your product throughout its lifecycle.

Pharmacovigilance & Device Vigilance

Patient Safety. Expertly Managed.

We build and operate robust safety systems from daily vigilance activities to reporting,
oversight and inspection readiness.

Quality Assurance

Quality Built into Every Stage.

We establish, operate and strengthen quality systems that support compliant daily
operations, market entry and continuous inspection readiness.

Market Access & Reimbursement

From Approval to Patient Access.

Excellence in Every Detail & Commitment at Every Step. Senior Expertise. Personal Accountability.

Your work is led by experienced professionals who remain directly involved
throughout the engagement. One accountable lead brings together the right expertise,
keeps the work moving and provides clarity on decisions, risks and
next steps. This continuity creates responsive, trusted partnerships and is why
many clients choose to work with StrugoPharm year after year.

Ready to Take the Next Step?

Tell us about your Pharmacovigilance, Regulatory Affairs, Quality Assurance or Market Access needs.

We’ll connect you directly with the right specialist to discuss the clearest path forward.

info@strugopharm.com +972.77.9100550