Services

Dor Pharmaceutical Services provides pharmas with trusted consulting and outsourcing services to companies launching and maintaining products in the Israeli market. Dor’s deep expertise and customer-focused approach deliver added value and peace of mind in the complex, dynamic Israeli regulatory environment.

Israeli Regulatory Affairs

In the dynamic, complex Israeli regulatory environment, Dor helps companies obtain marketing authorization and maintain compliance. Dor supports the entire medical product registration lifecycle, from new application submissions to maintenance of existing product licenses. Read more…

Validation Services

With Dor’s validation services, organizations can develop precise documentation and perfect their operations – confirming that throughout the product lifecycle, facilities, equipment, systems, processes and devices meet international regulatory and GxP compliance requirements. Read more…

International Regulatory Affairs

Dor helps companies successfully navigate the complicated regulatory landscape in Europe, the US and growth regions. Dor’s creative strategies help speed product time to market, enabling effective development and smooth marketing authorization review and approval processes. Read more…

Pharmaceutical Labeling and Localization

Dor’s  end-to-end pharma labeling and localization services for packaging, inserts and labels delivers added production value in the complex Israeli regulatory environment. With speed and quality, Dor adapts and translates all labeling elements to local regulatory requirements, formats and languages, graphically designs artwork and prints all packaging elements. Read more…

Qualified Person and Quality Assurance

Dor’s proven certified Qualified Person and Quality Assurance services help companies comply with GMP guidelines and Israeli Ministry of Health regulations. These oversight services cover new product launches and ongoing product maintenance, as well as investigational products (for clinical trial certification). Read more…

Pharmacovigilance and Medical Information

Dor helps medical product companies comply with safety regulations by delivering outsourced PV and device vigilance services, as well as medical information and contact center services. These services are a trusted lifeline for patients and healthcare providers for both marketed and clinical trial products. Read more…

Clinical Research

Dor’s world-class outsourcing service coordinates clinical trial operations and administration at Israel’s leading medical centers. A reliable, knowledgeable clinical development partner, Dor handles all the details so companies can focus on verifying product safety and effectiveness. Read more…

Proofreading technology

Dor Pharmaceutical Services delivers proofreading solutions to help pharmas and printing companies to eliminate printed artwork and copy related errors, providing end-to-end security at every stage of the packaging workflow. All our proofreading solutions meet FDA 21 CFR Part 11 / EMA Annex 11 requirements. Read more

GMP/GDP Auditing

Dor provides independent quality and regulatory audits to help medical product companies demonstrate supply chain compliance with GMP and GDP standards. Conformance audits cover the supply chain from end to end, both in Israel and abroad. Read more…