Regulatory Affairs

In the dynamic, complex Israeli (including Palestinian Authority) 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) from all type of applications (new molecular entity, generics, bio similar, drug-device combinations, advanced therapies, etc.), Medical Devices, Medical Cannabis, Cosmetics, Food supplements and 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.

The services include:

Regulatory Affairs

Regulatory affairs department outsourcing for Pharmaceuticals (Human and Veterinary), Medical Devices, Medical Cannabis, Cosmetics, Food supplements and Homeopathic products.

Qualified Person (QP)

Providing qualified person (QP) certification, outsourcing and insourcing, including batch release services.

Appointed Pharmacist / Regulatory Affairs Manager

New product approvals, dossiers, submission and follow-up for innovations or generics.

Post-approval support

Post-approval support (renewals, variations, import issues, etc.)

Labeling and Packaging

Labeling and Packaging with localization (patient leaflets, labels, packages, etc.), Promotional materials/activities for public and medical community.

Consulting

Business development, due diligence, Management consulting ,Regulatory second opinions ,Israeli license holder for your product registration.

Why Us

Expertise and our deep familiarity with regulatory requirements and registration procedures of the Ministry of Health that helps compliance and regulation, improves quality and accelerates the ready products.

Our staff are professionals in the pharmaceutical and medical industry focused on client goals.

Cost savings and flexibility - accessing services as needed, empowering companies and helping them complete tasks that would otherwise be too expensive to perform.

DOR empowers customer staff with effective training and ongoing knowledge transfer, as well as information updates on emerging industry and regulatory changes.