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| Regulatory support is crucial to all phases of the
drug development process. Veeda Oncology® is dedicated to providing you with regulatory support that is totally committed to the success of your program. Our focus is to assure compliance with all regulatory requirements. From a clinical trial perspective,
Veeda Oncology provides the following services: |
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- Comprehensive clinical trial document preparation/review
- Approval of investigator packets required for release of investigational product
- Develop and review informed consent forms
- Regulatory requirements for specific countries and regions
- GCP compliance
- Audits and corrective action plans
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| Additionally, Veeda Oncology can assist with IND and NDA filings to the US FDA as well as regulatory filings in Europe and parts of Asia. |
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| Veeda Oncology’s independent global Quality Assurance department is staffed by a team of experienced QA professionals in North America, Europe and India. The QA department is entirely separate from and independent of the personnel engaged in the direction and conduct of clinical trials. |
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| We perform audits in all stages of the project: |
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- Protocol audit
- Trial master file (TMF) audit
- Investigator site audit
- Database audit
- Report audit
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| Internal systems audits include a comprehensive review of procedures and processes followed in the management of clinical trials and are geared towards the identification of weaknesses as well as increased efficiencies. |
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| All audits are performed to assess adherence and compliance with Standard Operating Procedures (SOPs), Good Clinical Practice guidelines, regulatory requirements, the trial protocol, client instructions, and contractual obligations. |
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