Israeli Regulatory Affairs

In the dynamic, complex Israeli regulatory environment and registration process, Dor Pharmaceutical Services helps obtain swift marketing authorization for newly launched products in Israel. Dor also facilitates existing product license maintenance to ensure continued compliance. As Israel’s leading regulatory affairs consultancy, Dor helps clients minimize compliance-related risk while saving time and resources.

Dor Pharmaceutical Services consultants provide an extensive portfolio of professional regulatory services to support you through the lifetime of your product, and beyond. Experience with Israeli health regulators and detailed knowledge of local requirements and procedures result in swift approvals for your license applications and regulatory submissions for

  • Pharmaceuticals (Human and Veterinary)
  • Medical devices
  • Cosmetics
  • Food supplements
  • Homeopathic products

From large multinationals to small biotech firms, our regulatory affairs solutions are tailored to meet your exact requirements, from full regulatory affairs department outsourcing to filling appointed pharmacist or regulatory affairs functions to project management. We advance your products in the Israeli market by ensuring legal compliance, resolving issues with the Israeli Ministry of Health and keeping current with industry trends to advise on regulatory aspects affecting your objectives.

  • Regulatory affairs services include:

    Regulatory affairs department outsourcing

  • Qualified Person (QP) outsourcing, Read more…
  • Appointed pharmacist / regulatory affairs manager outsourcing/insourcing
  • New product approvals, dossiers, submission and follow-up for innovations or generics
  • Post-approval support (renewals, variations, import issues, etc.)
  • Line extensions
  • Labeling and Packaging with localization (patient leaflets, labels, packages, etc.)
  • Promotional materials/activities for public and medical community
  • Business development, due diligence
  • Management consulting
  • Regulatory second opinions
  • Israeli license holder for your product registration