Providing qualified person (QP) certification, outsourcing and insourcing, including batch release services (import and manufacturing batches)
Qualified Person / QP
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.
Cost savings and flexibility - accessing services as needed, empowering companies and helping them complete tasks that would otherwise be too expensive to perform.
DOR empowers customer staff with effective training and ongoing knowledge transfer, as well as information updates on emerging industry and regulatory changes.
