Regulatory affairs department outsourcing, Appointed Pharmacist/Regulatory Affairs Manager outsourcing/insourcing. Regulatory second opinion.
New product submissions and follow-up till approval for innovative and generic products.
Marketing Authorization Holder – MAH
Israeli product registration license holder (Marketing Authorization Holder – MAH)
Post-approval support (line extensions for additional indications/uses, renewals, variations, QA, Qualified Person, pharmacovigilance, import issue resolution, etc.), Business development and due diligence, Israeli and international regulatory affairs consulting.
Promotional materials/activities – for the public and medical community
Pharma Labeling and Localization
Dor’s end-to-end pharma labeling and localization service 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.
Qualified Person / Quality Assurance
Dor’s proven certified Qualified Person and Quality Assurance services help pharmas comply with GMP guidelines and Israeli Ministry of Health regulations
Dor delivers outsourced pharmacovigilance services, as well as medical information and contact center services as a trusted lifeline for patients and healthcare providers for both marketed and clinical trial products. Services are provided by Dor’s sister company Medicalix
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.