QP & QA


Dor Pharmaceutical Services provides a broad range of proven, certified Qualified Person (QP) and Quality Assurance (QA) services to help companies meet GMP guidelines and Israeli Ministry of Health (MOH) regulations. These oversight services cover new product launches and ongoing product maintenance, as well as investigational products (clinical trial certification). Dor’s services verify continued product safety, effectiveness and consumer satisfaction — from product manufacturing to the pharmacy shelf and beyond by:

Qualified Person / QP

Providing qualified person (QP) certification, outsourcing and insourcing, including batch release services (import and manufacturing batches)

Quality

Ongoing management of the quality system in accordance with the requirements of the Ministry of Health with constant readiness for review

Audits

Independent third-party audits, Comprehensive audit reports, Statements of compliance with GDP quality standards, Qualified, Regular audit report updates and re-auditing, GMP/GDP compliance programs, read more

Agreements

Creating quality agreements / technical agreements with suppliers.

Establishing and maintaining quality systems

Establishing and maintaining quality systems to meet local regulations (importer license) and international pharmaceutical standards (GMP and GDP)

SOP

Developing and maintaining standard operating procedures (SOP)

Pharmacovigilance

Conducting pharmacovigilance and device vigilance activities, Providing medical information to caregivers and patients

Documentation

Training teams and writing documentation, Managing complaints and contacts.

Clinical Trilas

Performing clinical trial quality assurance


Why Us


Expertise and our deep familiarity with regulatory requirements and registration procedures of the Ministry of Health that helps compliance and regulation, improves quality and accelerates the ready products.

Our staff are professionals in the pharmaceutical and medical industry focused on client goals.

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Cost savings and flexibility - accessing services as needed, empowering companies and helping them complete tasks that would otherwise be too expensive to perform.

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DOR empowers customer staff with effective training and ongoing knowledge transfer, as well as information updates on emerging industry and regulatory changes.