Providing qualified person (QP) certification, outsourcing and insourcing, including batch release services (import and manufacturing batches)
Qualified Person / QP
Ongoing management of the quality system in accordance with the requirements of the Ministry of Health with constant readiness for review
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
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)
Developing and maintaining standard operating procedures (SOP)
Conducting pharmacovigilance and device vigilance activities, Providing medical information to caregivers and patients
Training teams and writing documentation, Managing complaints and contacts.
Performing clinical trial quality assurance