For global companies
Build a practical regulatory approach for Israel, assess your local operating needs, and coordinate registration and ongoing product maintenance with your global teams and local partners.
Explore support for your businessREGULATORY AFFAIRS & PHARMA CONSULTING
Your regulatory
affairs partner.
In Israel.
Senior expertise. Personal commitment.
Medicalix Ltd. provides regulatory affairs outsourcing, registration and lifecycle management in Israel for human medicines and medical devices. We support global companies, Israeli affiliates, importers and manufacturers.
Led by Avner Dor. Work directly with Avner, supported by specialist partners according to your project’s needs.
30+
Years in regulated healthcare
Pfizer Israel
Former Regulatory Affairs Manager & Head of Country Clinical Operations
Dor Pharmaceutical Services
Founded in 2011. Sold to Novolog Ltd. in 2021.
WHO WE SUPPORT
Global ambition. Local expertise.
For Israeli affiliates, importers and manufacturers
Add experienced regulatory capacity to your business. Support an individual submission, strengthen your existing team, or outsource ongoing regulatory activities.
Explore support for your businessOUR EXPERTISE
From strategy to ongoing regulatory operations
A single project or ongoing support. The right expertise, shaped around your business.
Discuss your prioritiesBrowse all regulatory services01Regulatory outsourcing & Appointed Pharmacist
Including Appointed Pharmacist services
Full or partial outsourcing of regulatory activities, with Appointed Pharmacist services where applicable. Flexible support for ongoing operations, temporary absences and periods of increased workload.
Discuss this service02Registration & submissions
Support for new medicine registrations, generics, biologics, line extensions and medical device registration. Review dossier readiness, coordinate local submission requirements, and manage responses to Ministry of Health queries.
Discuss this service03Product lifecycle management
Manage renewals, variations, labeling and leaflet updates, and regulatory changes across your registered portfolio. Coordinate documentation and local requirements with manufacturers and global regulatory teams.
Discuss this service04Strategy & senior advisory
Practical guidance on Israel market entry, registration planning and regulatory priorities. Senior support for management and regulatory teams, including dossier gap assessment, launch planning and regulatory input to business development.
Discuss this service05Quality assurance, QP & QPPV consulting
Advice on quality systems, GMP/GDP processes, batch-release readiness and pharmacovigilance arrangements. Support can include gap reviews, procedures and clarification of responsibilities, tailored to your company’s needs.
Consulting only: this service does not include appointment as QP or QPPV, QP batch certification or release, or outsourced operation of these functions.
Discuss this serviceEXPERIENCE BEHIND THE EXPERTISE
About Medicalix
Medicalix provides regulatory affairs outsourcing and pharma consulting in Israel, led by Avner Dor and supported by specialist partners. We work with global companies, Israeli affiliates, importers and manufacturers of human medicines and medical devices. Our approach combines direct senior involvement with a scope tailored to each client.
Meet Avner Dor
I lead Medicalix’s regulatory affairs and consulting engagements. I am a licensed pharmacist with more than 30 years of experience in regulated healthcare, spanning regulatory affairs, quality assurance, QP practice, pharmacovigilance and clinical operations.
At Pfizer Israel, I served as Regulatory Affairs Manager and Head of Country Clinical Operations. After leaving Pfizer, I established Dor Pharmaceutical Services in 2011. Under my leadership, Dor became Israel’s leading and largest regulatory affairs and quality assurance service provider. I sold the company to Novolog Ltd. in 2021.
More about my professional background
My background combines multinational affiliate experience, regulatory leadership at Trima Pharmaceuticals, and building and managing multidisciplinary outsourced services. It spans registration and lifecycle management, quality systems, QP support, pharmacovigilance, labeling and clinical research support. Today, I lead client engagements personally and involve specialist partners according to each project’s needs.
I also provide consulting in quality assurance, QP and QPPV matters, drawing on my professional knowledge and leadership experience across these disciplines. This advisory work complements my regulatory outsourcing services; I do not provide appointed QP or QPPV services or undertake QP batch certification and release.
B.Pharm., Hebrew University of JerusalemM.Sc., Pharmaceutical Medicine, Hibernia CollegeLicensed PharmacistAppointed PharmacistQP experienceExpertise in quality assurance and pharmacovigilance
Explore Avner Dor’s professional backgroundESTABLISH YOUR LOCAL FOOTPRINT
Local legal entity support in Israel
Your regulatory plan also needs an appropriate local operating structure. Medicalix, led by Avner Dor, helps assess and arrange a local legal entity solution for your Israeli activities, taking account of the product, business model and responsibilities involved.
The entity’s role, required authorizations and division of responsibilities are defined for each engagement.
Discuss Your Local SetupExplore local entity optionsBUILT AROUND YOUR BUSINESS
Flexible ways to work together
Ongoing outsourcing
Full or partial regulatory support integrated with your company’s working processes.
Project support
A defined scope for a registration, submission, portfolio update or market-entry project.
Interim coverage
Support during leave, vacancies, transitions or workload peaks.
A CLEAR WAY FORWARD
How we get started
Understand your needs
Discuss your products, current regulatory position, local setup and priorities.
Define the scope
Agree on responsibilities, deliverables and the appropriate support model.
Begin delivery
Coordinate the work with your team and relevant partners, with clear communication on progress and open items.
GOOD TO KNOW
Regulatory support in Israel: your questions
Can Medicalix support a company without an Israeli entity?
Yes. We can assess your regulatory and local entity needs together and define a suitable operating model before implementation.
Can Medicalix support our existing regulatory team?
Yes. Support can cover specific activities, projects or temporary capacity alongside your internal team.
Can we outsource the Appointed Pharmacist role?
Appointed Pharmacist services can be included where applicable, with the scope and appointment requirements agreed for the engagement.
Does Medicalix support medicines and medical devices?
Yes. The service covers human medicines, including generics and biologics, and medical devices. The scope is tailored to the relevant product category.
Does Medicalix provide appointed QP or QPPV services?
Medicalix offers consulting in both areas, led by Avner Dor, including quality and pharmacovigilance arrangements and support for the responsible teams. We do not provide appointed QP or QPPV services, QP batch certification and release, or operational pharmacovigilance outsourcing.
Can we communicate in English or Hebrew?
Yes. Both languages are available for client communication.
What should we prepare for an introductory call?
Share a non-confidential overview of your product category, existing registrations, intended activities in Israel, priorities and timelines. We can then discuss the scope, responsibilities and documents needed for your engagement.
LET’S TALK
Let’s discuss your regulatory needs in Israel
Contact Medicalix to discuss your company, product and the support you need. Avner Dor will follow up to define a suitable scope.
English & Hebrew. Direct senior involvement.