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Regulatory Services in South AfricaThe reason regulations are stringent is to ensure maximum patient safety along the entire drug development pipeline- from research to post-marketing activities. Maintaining compliance with regulatory requirements is crucial as it ensures patient safety. For this reason, as pharmaceutical products progress through their life cycle, they must be compliant to laws, procedures, and regulations set by authorities. Similarly, pharmacovigilance and quality systems that are put in place must consistently be reviewed and verified by conducting regular audits.
DDReg’s Audit personnel review all pharmacovigilance systems and their implementation and operation. Our team is committed to ensuring that all pharmacovigilance processes are in adherence to regulatory requirements such as ICH guidelines, E2B(R3), E2C(R2), GVP modules, FDA, E2E etc. Additionally, DDReg provides training in PV Audit to ensure that the organization’s staff are aware of maintaining compliance to such regulatory requirements.
DDReg Audit and Compliance Expertise:
- Experienced and highly educated and trained on subjects related to PV audits
- Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
- Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
- Conducts regular gap assessments of PV staff at site location
- Provides organizational training on safety audits and inspections
