End-to-End Solution: Medical Product Registration and Labeling

Dor Pharmaceutical Services delivers an all-encompassing solution covering the entire regulatory process, from product registration through label and packaging development/production and printing. The solution supports both new marketing authorization applications as well as post-approval support, such as existing product license renewal and variation handling.
With extensive medical product experience, specialized knowledge of the Israeli regulations and exclusive focus on the Israeli market, Dor’s best practice approach lets companies offload tedious and time-consuming registration localization and labeling tasks, to trusted experts who are meticulous about the outcome.

All-inclusive solution

The solution for new product applications/new drug applications (NDA) covers:

1. Collecting raw data from the manufacturer
• Assembling documents, standards, declarations and certifications
• Obtaining/importing product samples

2. Preparing the registration dossier for submission
• Customizing the application dossier to local requirements
• Working with the manufacturer to create the dossier

3. Localizing – Translating the following material into Hebrew and adapting content to Israeli standards:
• Patient leaflet
• Physician leaflet
• Product label and package

4. Submitting application and following up until approval is obtained
• Submitting request to the Israel Ministry of Health (MOH)
• Addressing deficiency letters and making updates accordingly
• Obtaining the certificate of registration (marketing authorization, product license)

5. Translating the patient leaflet into English and Arabic (and Russian, as necessary)

6. Graphically designing the packaging material artwork, including pagination and layout, design of multi-lingual text and graphic elements (e.g., logos), adding barcode and pharmacode, and preparing deliverables in print-ready graphics files.

7. Printing all packaging labeling using offset and digital print processes (as needed), supporting color ranges from multi-color to 8 colors and a variety of label substrates.

Dor also performs prompt quality product license renewals and provides registration and localization/labeling services on a stand-alone basis.

Beginning-to-end project responsibility

The Dor team is the single point of contact, fully accountable for the quality and timeline of the entire project, which eliminates coordination hassles between multiple organizations. This means that customers can rest assured that Dor’s subject matter experts thoroughly cover all aspects of a project so that nothing falls through the cracks. Proficiency in the entire regulatory process means that Dor’s investment in beginning-stage efforts sets the foundation for later stage activities. This forward-thinking expertise gets it right the first time, which accelerates time to market—without compromise.
The Dor approach is ideal for companies that wish to fast-track a new innovation or newly imported product.

Ensuring compliance and quality

Because Dor is well-seasoned in the licensing processes required to obtain marketing authorization, Dor makes product registration a routine operation. Maintaining a rigorous proven quality program, Dor helps ensure adherence to Israeli Ministry of Health (MOH) regulations. Companies gain the peace of mind that Dor procedures meet the highest standards, such as Good Manufacturing Practices (GMP). This enables customers to benefit from thorough quality deliverables, fewer review rounds and reduced risk.

State-of-the-art tools and technologies

Dor’s use of the latest technologies differentiates services for customers, offering maximum flexibility and responsiveness. Simplified and automated processes rely on electronic files, eliminating the burden of paper-based management (submissions, review cycles, archiving, etc.). The result is a streamlined workflow that speeds application turnaround and labeling, and, most importantly—product introduction. Customers receive softcopy files, so they can rest assured they hold the most accurate, up-to-date version, and are empowered to decide how to maintain the documents in the future.