Dor Pharmaceutical Services
DOR Pharmaceutical Services is a leading service providers for the Pharmaceutical, Medical Device and Food Supplement industries in Israel DOR delivers an integrated portfolio of outsource services in Regulatory Affairs, Quality Assurance (including Qualified Person), Clinical Trials (CRO), Pharmacovigilance services and artwork localization/translation in Israel.
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| | |
| DOR Pharmaceutical Services | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 2011 |
| Headquarters | Kochav Yair |
| Number of employees | 11-50 employees |
Contents
History
Dor Pharmaceutical Services was founded in 2011 with a clear mission: to empower the development, approval, commercialization and monitoring of safe, effective pharmaceutical products, medical devices, food supplements and cosmetics in Israel, the US, Europe and growth regions.
Dor offers sound, practical regulatory affairs, quality and labeling consulting and outsourcing services as well as comprehensive pharmacovigilance and clinical research support. These essential services enable clients to extend existing resources, expedite regulatory approvals, and meet clinical development goals, while expanding market penetration and realizing significant productivity gains and cost savings.
Based in Israel, the Dor Pharmaceutical Services team of seasoned pharmaceutical industry professionals is focused on client goals with expertise and integrity, innovation and excellence, and a commitment to unsurpassed service and support. Dor Pharmaceutical Services is ISO 9001:2008 certified
Services
- Israeli Regulatory Affairs
- International Regulatory Affairs
- Pharmaceutical labeling
- QP / Quality Assurance
- Pharmacovigilance
- Clinical Research
- Proofreading Technology
- GMP/GDP Auditing
Pharmacovigilance
Pharmacovigilance
Dor Pharmaceutical Services delivers pharmacovigilance (PV) and device vigilance, medical information (MI) and contact center services to help pharmas and device companies comply with safety regulations. These outsourced services enable companies to provide the trusted lifeline that patients and healthcare providers rely on for both marketed and clinical trial products.
Dor partners with Medicalix, the PV and MI experts in Israel, to provide this range of quality services, which includes:
Pharmacovigilance and device vigilance
Full-service outsourcing of adverse-event intake and processing and product complaint documentation, or select services to complement your existing drug safety operation, featuring:
- Qualified person for pharmacovigilance (QPPV)
- Preparation of periodic reports, such as periodic safety update reports (PSUR) and annual safety reports (ASR) and ad hoc reports
- Documentation and analysis of case data
- Signal detection and risk-benefit analyses
- Patient safety and risk management support
- Literature searches for case identification and reporting
- Training courses on PV and device vigilance regulations and procedures
Medical information services
Knowledgeable responses to healthcare provider and patient inquiries on your behalf—managed by skilled and sensitive medical professionals, which includes:
- Sharing product information, such as: usage, side effects, drug-drug interactions, disease applications and optimizing effectiveness
- Comprehensive contact center and reporting services
- Development of frequently asked questions (FAQ) database for company responses to medical inquiries
- Supporting challenging products, such as those that are complex, controversial or have not yet gained market acceptance
Contact center
- Professionally staffed call center by knowledgeable, specially trained, responsive healthcare professionals
- Leveraged contact methods most convenient for your target audience (phone, email, fax, etc.)
- Customer relationship management services [1]
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